A Study to Compare the Pharmacokinetics (PK) of Salbutamo... | NCT06433908

ID	Type	Description	Link
2023-508279-36-00	Other Identifier	EU CT number

Label	Type	Description	Intervention Names
Cohort 1: Salbutamol 200 μg	Experimental	Participants will receive single 200 μg doses given as 2x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10.	Drug: Salbutamol HFA-152a Drug: Salbutamol HFA-134a
Cohort 2: Salbutamol 800 μg	Experimental	Participants will receive single 800 μg doses given as 8x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10.	Drug: Salbutamol HFA-152a Drug: Salbutamol HFA-134a

Name	Type	Description	Arm Group Labels	Other Names
Salbutamol HFA-152a	Drug	100 µg (ex-valve), given at 20-second intervals.	Cohort 1: Salbutamol 200 μg Cohort 2: Salbutamol 800 μg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])	Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.	At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])	Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.	At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Cohort 1: Maximum Observed Plasma Concentration (Cmax)	Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.	At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])	Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.	At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)
Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])	Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.	At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

Secondary Outcomes

Measure	Description	Time Frame
Cohort 1: Time to Reach Cmax (Tmax)	Blood samples were collected for the analysis of PK parameters.	At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal.
Age: 18 to 55 years inclusive.
Weight: 45 to 110 kg inclusive
Status: healthy participants.
Females must not be pregnant or lactating.
All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center based on investigator judgment. An exception is made for hormonal contraceptives, which may be used throughout the study.
All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center based on investigator judgment. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center.
Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening, and from 48 hours (2 days) prior to admission until discharge from the clinical research center.
Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission until discharge from the clinical research center.
Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator.
Serum potassium and serum glucose levels within reference ranges of the clinical research center.
Willing and able to sign the informed consent form.
Spirometry at screening demonstrating forced expiratory volume ≥80% predicted.

Exclusion Criteria:

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
At screening, systolic blood pressure <90 mmHg or >140 mmHg, or diastolic blood pressure <50 mmHg or >90 mmHg.
History of pathological tachycardia, or a pulse rate > 85 beats per minute (bpm) at screening or Day-1.
Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Breast cancer within the past 10 years.
A QTcF value of >450 msec at screening based on a triplicate measurement taken at a single timepoint.
Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study.
Donation or loss of more than 450 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 L of blood (for male participants) or more than 1.0 L of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study.
Participation in a drug study within 30 days prior to (the first) drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to (the first) drug administration in the current study.
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention.
Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. NOTE: Participants with positive hepatitis C antibody test result due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C RNA test is obtained.
Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
Positive HIV antibody test.
Cotinine levels indicative of smoking or history or use of tobacco- or nicotine containing products within 6 months prior to screening.

Assessment as ineligible by the investigator based on the results of the clinical laboratory tests or other assessments.
Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
Regular use of known drugs of abuse, including tetrahydrocannabinol.
Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 6 months prior to screening.
Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.).
Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator/delegate.

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Groningen		9728	Netherlands

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 2, 2024	Oct 17, 2025

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
BG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10
BG002	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
BG003	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Cohort 1: Time to Reach Cmax (Tmax)

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Median

Full Range

Hour (h)

At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Units	Counts
Participants	OG00030 OG00130

Title

Denominators

Categories

Day 1

- ParticipantsOG00016
- ParticipantsOG00114

Title	Measurements
	OG0002.00(0.3 to 3.0)

Secondary

Cohort 1: Apparent Terminal Phase Half-life (t1/2)

Blood samples were collected for the analysis of PK parameters.

Posted

Mean

Standard Deviation

Hour (h)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 1: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population

Posted

Geometric Least Squares Mean

95% Confidence Interval

h*pg/mL

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug (2 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug (2 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts
Participants

Secondary

Cohort 1-Intra-Participant Variability of AUC (0-30min)

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Number

Percentage of Coefficient Variation

At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug (2 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug (2 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.

Units	Counts
Participants

Secondary

Cohort 1: Intra Participant Variability of AUC (0-infinity)

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population

Posted

Number

Percentage of Coefficient Variation

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug (2 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug (2 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.

Units	Counts
Participants

Secondary

Cohort 1: Intra Participant Variability of AUC(0-last)

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population

Posted

Number

Percentage of Coefficient Variation

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug (2 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug (2 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts
Participants

Secondary

Cohort 1: Intra Participant Variability of Cmax

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population

Posted

Number

Percentage of Coefficient Variation

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug (2 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug (2 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts
Participants

Secondary

Cohort 1: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Safety Population included all participants who received at least one puff/actuation of study intervention.

Posted

Count of Participants

Participants

Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 µg (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 1: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 1: Absolute Values for 12 Lead ECGs Recording of QT Interval Corrected Using Fridericia's Formula (QTcF) Intervals

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

milliseconds (ms)

Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 1: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

milliseconds (ms)

Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 1: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count

Blood samples were collected for analyzing absolute values of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet count. Baseline is defined as the latest non-missing pre-dose value

Safety Population. As outlined in the protocol, clinical laboratory data were collected at baseline and discharge, hence the data were analyzed and presented by treatment sequence. Each participant was counted only once for this analysis.

Posted

Mean

Standard Deviation

Giga cells/Liter

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values of Hematology Parameter: Erythrocytes

Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

Trillion cells/Liter

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

femtoliter (fL)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

femtomole (fmol)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values of Hematology Parameter: Hemoglobin

Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

gram per liter (g/L)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values of Hematology Parameter: Hematocrit

Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

Percentage of red blood cells in blood

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

Blood samples were collected for analyzing absolute values of Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Creatine Phosphokinase (CPK). Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

International Units per Liter (IU/L)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine

Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

micromoles per liter (umol/L)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen

Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 1: TRRT1	Healthy participants in Cohort 1 received TRRT1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 1: RTTR1	Healthy participants in Cohort 1 received RTTR1, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 200 ug (2 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 200 ug (2 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 1: Absolute Values for Chemistry Parameter: Glucose and Potassium

Blood samples were collected for analyzing absolute values of glucose and potassium

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 1: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

SBP and DBP measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 1: Absolute Values of Pulse Rate (PR)

Pulse rate measurements were assessed with a completely automated device after the participant has been resting for at least 5 minutes in the supine position. Manual techniques were used only if an automated device was not available.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 1. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Time to Reach Cmax (Tmax)

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Median

Full Range

Hour

At pre-dose, 3, 5, 10, 15, 20, 30, and 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 [ Period 3] and Day 10 [Period 4]

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Apparent Terminal Phase Half-life (t1/2)

Blood samples were collected for the analysis of PK parameters.

Posted

Mean

Standard Deviation

Hour

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Least Squares Mean

95% Confidence Interval

h*pg/mL

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a (Test) via MDI as single dose of 800 ug (8 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug (8 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.

Secondary

Cohort 2-Intra-Participant Variability of AUC (0-30min)

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Number

Percentage of Coefficient Variation

At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a (Test) via MDI as single dose of 800 ug (8 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug (8 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts
Participants

Secondary

Cohort 2: Intra Participant Variability of AUC (0-infinity)

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Number

Percentage of Coefficient Variation

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a (Test) via MDI as single dose of 800 ug (8 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug (8 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts

Secondary

Cohort 2: Intra Participant Variability of AUC (0-last)

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Number

Percentage of Coefficient Variation

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a (Test) via MDI as single dose of 800 ug (8 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug (8 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts

Secondary

Cohort 2: Intra Participant Variability of Cmax

Blood samples were collected for the analysis of PK parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Number

Percentage of Coefficient Variation

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a (Test) via MDI as single dose of 800 ug (8 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug (8 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.

Units	Counts

Secondary

Cohort 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Safety Population included all participants who received at least one puff/actuation of study intervention.

Posted

Count of Participants

Participants

Up to 46 days [From ICF signing (Day -28) until telephonic follow-up (Day 18)]

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 µg (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the HR and were measured after resting for at least 5 minutes in the supine position.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Absolute Values for 12 Lead ECGs Recording of QTcF Intervals

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

milliseconds (ms)

Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of HR

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated HR and were measured after resting for at least 5 minutes in the supine position.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Change From Baseline (CFB) for Post-dose 12 Lead ECGs Recording of QTcF Intervals

A standard 12 lead ECG was obtained using an ECG machine that automatically calculated the QTcF Interval and were measured after resting for at least 5 minutes in the supine position.

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

milliseconds

Baseline (pre-dose) and post-dose at 30 minutes on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3], Day 10 [Period 4] and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Absolute Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Platelet Count

Posted

Mean

Standard Deviation

Giga cells/Liter

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values of Hematology Parameter: Erythrocytes

Blood samples were collected for analyzing absolute values of Erythrocytes. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

Trillion cells/Liter

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV)

Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

femtoliter (fL)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

femtomole (fmol)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values of Hematology Parameter: Hemoglobin

Blood samples were collected for analyzing absolute values of Hemoglobin. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

gram per liter (g/L)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values of Hematology Parameter: Hematocrit

Blood samples were collected for analyzing absolute values of Hematocrit. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

Percentage of red blood cells in blood

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values of Clinical Chemistry Parameters, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK)

Posted

Mean

Standard Deviation

International Units per Liter (IU/L)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Total Protein and Creatinine

Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin, total protein and Creatinine. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

micromoles per liter (umol/L)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values for Chemistry Parameters: Calcium, Sodium, Urea Nitrogen

Blood samples were collected for analyzing absolute values of Calcium, Sodium and Urea Nitrogen. Baseline is defined as the latest non-missing pre-dose value

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline (Day -1) and Day 11 (Discharge)

ID	Title	Description
OG000	Cohort 2: TRRT2	Healthy participants in Cohort 2 received TRRT2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 1, Day 10 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 4, Day 7
OG001	Cohort 2: RTTR2	Healthy participants in Cohort 2 received RTTR2, where "T" represents Salbutamol Hydrofluoroalkane (HFA)-152a (Test) via metered dose inhalers (MDI) as a single 800 ug (8 x 100 µg) administered at 20-second intervals on Day 4, Day 7 and "R" represents Salbutamol HFA-134a (Reference) via MDI as a single 800 ug (8 x 100 µg), administered at 20-second intervals on Day 1, Day 10

Secondary

Cohort 2: Absolute Values for Chemistry Parameter: Glucose and Potassium

Blood samples were collected for analyzing absolute values of glucose and potassium

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 1.5, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

millimeters of mercury(mmHg)

Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Secondary

Cohort 2: Absolute Values of Pulse Rate (PR)

Safety Population. "Overall Number of Participants Analyzed" included the total number of participants in Cohort 2. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (Pre-dose) and Post-dose at 15, 30 minutes and 1, 2 and 4 hours on Day 1 [Period 1], Day 4 [Period 2], Day 7 [Period 3] and Day 10 [ Period 4]

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).

Primary

Cohort 1: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Pharmacokinetic Population included all participants in the Full Analysis Set who had at least 1 non-missing assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Least Squares Mean

95% Confidence Interval

Hour * Picogram per Milliliter (h*pg/mL)

At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug (2 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug (2 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Primary

Cohort 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Pharmacokinetic Population

Posted

Geometric Least Squares Mean

95% Confidence Interval

h*pg/mL

At pre-dose, 3, 5, 10, 15, 20, 30, 45 minutes post-dose and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug (2 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug (2 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts
Participants

Primary

Cohort 1: Maximum Observed Plasma Concentration (Cmax)

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Pharmacokinetic Population

Posted

Geometric Least Squares Mean

95% Confidence Interval

Picogram per milliliter (pg/mL)

ID	Title	Description
OG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug (2 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10.
OG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug (2 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts
Participants

Primary

Cohort 2: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post- Dose (AUC[0-30])

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Least Squares Mean

95% Confidence Interval

Hour * Picogram per Milliliter (h*pg/mL)

At pre-dose, 3, 5, 10, 15, 20 and 30 minutes post-dose on Day 1 (Period 1), Day 4 (Period 2), Day 7 (Period 3) and Day 10 (Period 4)

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a (Test) via MDI as single dose of 800 ug (8 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug (8 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts

Primary

Cohort 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-infinity])

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Least Squares Mean

95% Confidence Interval

h*pg/mL

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a (Test) via MDI as single dose of 800 ug (8 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug (8 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units

Primary

Cohort 2: Maximum Observed Plasma Concentration (Cmax)

Blood samples were collected for the analysis of Pharmacokinetic (PK) parameters.

Pharmacokinetic Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Geometric Least Squares Mean

95% Confidence Interval

Picogram per milliliter (pg/mL)

ID	Title	Description
OG000	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a (Test) via MDI as single dose of 800 ug (8 x 100 µg) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10
OG001	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug (8 x 100 ug) as inhalation suspension at 20 second intervals on Day 1, Day 4, Day 7 and Day 10

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: Salbutamol HFA-152a MDI 200 ug (Test)	Healthy participants in cohort 1 received Salbutamol HFA-152a (Test) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).	30	1	30	12	30
EG001	Cohort 1: Salbutamol HFA-134a MDI 200 ug (Reference)	Healthy participants in cohort 1 received Salbutamol HFA-134a (Reference) via MDI as single dose of 200 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).	30	0	30	7	30
EG002	Cohort 2: Salbutamol HFA-152a MDI 800 ug (Test)	Healthy participants in cohort 2 received Salbutamol HFA-152a via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 1 and Day 10 in the first sequence (TRRT) and Day 4 and Day 7 in the second sequence (RTTR), where T is salbutamol HFA-152a (test) and R is salbutamol HFA-134a (reference).	30	0	30	16	30
EG003	Cohort 2: Salbutamol HFA-134a MDI 800 ug (Reference)	Healthy participants in cohort 2 received Salbutamol HFA-134a (Reference) via MDI as single dose of 800 ug as inhalation suspension at 20 second intervals administered on Day 4 and Day 7 in the first sequence (TRRT) and Day 1 and Day 10 in the second sequence (RTTR), where R is salbutamol HFA-134a (reference) and T is salbutamol HFA-152a (test).	30	0	29	21	30

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Catheter site haematoma	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0005 events5 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected30 at risk EG0030 events0 affected30 at risk
Catheter site irritation	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected30 at risk EG0012 events2 affected30 at risk EG0020 events0 affected30 at risk EG003
Catheter site related reaction	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0029 events9 affected30 at risk EG003
Fatigue	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected30 at risk EG003
Headache	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0003 events3 affected30 at risk EG0012 events2 affected30 at risk EG0025 events5 affected30 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected30 at risk EG003
Hot flush	Vascular disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected30 at risk EG0020 events0 affected30 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0024 events3 affected30 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0022 events2 affected30 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0023 events2 affected30 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0022 events2 affected30 at risk EG003
Vessel puncture site haematoma	General disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected30 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA Version 27.1	Systematic Assessment	EG0002 events2 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected30 at risk EG003

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases