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This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salbutamol HFA-152a MDI followed by Salbutamol HFA-134a MDI | Experimental | Participants will receive Salbutamol HFA-152a MDI in treatment period 1 followed by Salbutamol HFA-134a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period. |
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| Salbutamol HFA-134a MDI followed by Salbutamol HFA-152a MDI | Experimental | Participants will receive Salbutamol HFA-134a MDI in treatment period 1 followed by Salbutamol HFA-152a MDI in treatment period 2. There will be a minimum washout period of 72 hours between each treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol HFA-152a | Drug | Salbutamol HFA-152a will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4 |
| AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
| AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
| Maximum Observed Plasma Concentration (Cmax) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (Tmax) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
| Apparent Terminal Phase Half-life (t1/2) of Salbutamol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Groningen | 9728 NZ | Netherlands |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Salbutamol HFA-152a MDI Followed by Salbutamol HFA-134a MDI | Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-152a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period. |
| FG001 | Salbutamol HFA-134a MDI Followed by Salbutamol HFA-152a MDI | Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-134a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, Salbutamol HFA-152a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) via inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day 1) |
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| Washout Period (Minimum 72 Hours) |
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| Period 2 (Day 4) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Salbutamol HFA-152a MDI Followed by Salbutamol HFA-134a MDI | Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-152a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Hour*nanogram/milliliter (h*ng/mL) | Pre-dose and post dose 3, 5, 10, 15, 20 and 30 minutes on Day 1 and Day 4 |
|
All-cause mortality, serious adverse events (SAEs) were collected from signing of the ICF, and all Adverse Events (AEs) were collected from start of study treatment up to Day 5 (discharge).
Safety population included all participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Salbutamol HFA-152a MDI | Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2023 | May 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2023 | May 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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This is a 2-way cross-over study.
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This will be a double-blind study.
| Salbutamol HFA-134a | Drug | Salbutamol HFA-134a will be administered. |
|
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. |
| Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
| Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol | Minimum observed concentration of potassium levels after dose are presented. | 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
| Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K) | Weighed mean of serum potassium was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 * (t2-t1), where C2 and t2 are serum potassium and timepoint at the end of each interval, and C1 and t1 are serum potassium and timepoint at the start of each interval. | Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
| Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol | Maximum observed heart rate (HR) after dose is presented. | 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
| Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR) | Weighed mean of HR was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 * (t2-t1), where C2 and t2 are HR and timepoint at the end of each interval, and C1 and t1 are HR and timepoint at the start of each interval. | Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
| Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol | Maximum observed QTcF after dose are presented. | 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
| Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF) | Weighed mean of QTcF was calculated as summation of each interval. Each interval calculated as: [(C2+C1)/2×(t2-t1)]/Total time (Tlast-Tfirst, ie 4-0 hour) where C2 and t2 are concentration and timepoint at the end of each interval, and C1 and t1 are concentration and timepoint at the start of each interval. Tlast is the end of the last collection interval, and Tfirst is the start of the first collection interval. | Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary). | Up to 5 days |
| Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval | A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline is defined as the last observation recorded before the first study drug administration in each dosing period. | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
| Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval | A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements. | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
| Absolute Values of ECG Parameter: Heart Rate | A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements. | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
| Change From Baseline in ECG Parameters: Heart Rate | A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements. | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
| Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Blood samples were collected for analyzing absolute values of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count | Blood samples were collected for analyzing absolute values of red blood cell (RBC) and reticulocytes count. | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values of Hematology Parameter: Hemoglobin | Blood samples were collected for analyzing absolute values of Hemoglobin. | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values of Hematology Parameter: Hematocrit | Blood samples were collected for analyzing absolute values of Hematocrit. | On Day -1 (admission) and Day 5 (Discharge) |
| 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). | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine | Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin and Creatinine. | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values of Clinical Chemistry Parameter: Total Protein | Blood samples were collected for analyzing absolute values of Total protein. | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN) | Blood samples were collected for analyzing absolute values of Calcium, Sodium, Potassium, Blood Urea Nitrogen. | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values for Chemistry Parameter: Glucose | Blood samples were collected for analyzing absolute values of glucose. | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
| Number of Participants With Urinalysis Parameters by Dipstick Method | Urine samples were collected to assess glucose, ketones, occult blood, protein, urobilinogen and bilirubin by dipstick method. The dipstick test gave results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Results are presented as'(+)' indicating 'equivocal', '+' indicating 'trace amount', '++' indicating 'positive', and 'negative'. | On Day -1 (admission) and Day 5 (Discharge) |
| Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Blood pressure 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. | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
| Absolute Values of Pulse Rate | 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. | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
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| BG001 | Salbutamol HFA-134a MDI Followed by Salbutamol HFA-152a MDI | Healthy participants received Salbutamol Hydrofluoroalkane (HFA)-134a metered dose inhaler (MDI) suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) inhalation on Day 1 of treatment period 1. In treatment period 2, Salbutamol HFA-152a MDI suspension as a single 800 µg (8 x 100 µg dose at 20-second intervals) via inhalation on Day 4. There was a minimum washout period of 72 hours between each treatment period. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-152a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2).
| OG001 | Salbutamol HFA-134a MDI | Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2). |
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| Primary | AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Hour*nanogram/milliliter (h*ng/mL) | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
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| Primary | AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Hour*nanogram/millilitre (h*ng/mL) | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | nanogram/millilitre (ng/mL) | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
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| Secondary | Time to Cmax (Tmax) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis. | Posted | Median | Full Range | hour (h) | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
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| Secondary | Apparent Terminal Phase Half-life (t1/2) of Salbutamol | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population included all participants in the safety population who received at least one dose of study treatment and had at least one non-missing PK assessment. Only those participants with data available at specified time points have been analyzed. 1 participant in Salbutamol HFA-152a MDI arm had out of window samples resulting in two samples with the same collection time. Therefore, data could not be calculated and were excluded from the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour (h) | Pre-dose and post dose 0.05, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours on Day 1 and Day 4 |
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| Secondary | Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol | Minimum observed concentration of potassium levels after dose are presented. | Pharmacodynamic population included all participants who received at least one dose of study intervention and have at least one non-missing potassium concentration result. Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | millimoles per liter (mmol/L) | 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
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| Secondary | Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K) | Weighed mean of serum potassium was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 * (t2-t1), where C2 and t2 are serum potassium and timepoint at the end of each interval, and C1 and t1 are serum potassium and timepoint at the start of each interval. | Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | millimoles per liter (mmol/L) | Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
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| Secondary | Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol | Maximum observed heart rate (HR) after dose is presented. | Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Beats per minute (beats/min) | 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
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| Secondary | Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR) | Weighed mean of HR was calculated as summation of each interval. Each interval calculated as: (C2-C1)/2 * (t2-t1), where C2 and t2 are HR and timepoint at the end of each interval, and C1 and t1 are HR and timepoint at the start of each interval. | Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Beats per minute (beats/min) | Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
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| Secondary | Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol | Maximum observed QTcF after dose are presented. | Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Milliseconds | 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
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| Secondary | Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF) | Weighed mean of QTcF was calculated as summation of each interval. Each interval calculated as: [(C2+C1)/2×(t2-t1)]/Total time (Tlast-Tfirst, ie 4-0 hour) where C2 and t2 are concentration and timepoint at the end of each interval, and C1 and t1 are concentration and timepoint at the start of each interval. Tlast is the end of the last collection interval, and Tfirst is the start of the first collection interval. | Pharmacodynamic Population. Only those participants with data available at specified time points have been analyzed. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Milliseconds | Pre-dose and 0.25, 0.5, 1, 1.5, 2 and 4 hours post-dose on each dosing day (Days 1 and 4) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pre-treatment or worsens relative to the pre-treatment state. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary). | Safety population included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 5 days |
|
|
|
| Secondary | Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval | A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Baseline is defined as the last observation recorded before the first study drug administration in each dosing period. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
|
|
|
| Secondary | Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval | A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
|
|
|
| Secondary | Absolute Values of ECG Parameter: Heart Rate | A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
|
|
|
| Secondary | Change From Baseline in ECG Parameters: Heart Rate | A standard 12-lead ECG was obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and QTcF intervals. The ECG was obtained after the participant has been resting for at least 5 minutes in the supine position. Pre-dose 12-lead ECG was measured in triplicate. The 3 pre-dose measures was averaged for QTc interval and HR to derive one baseline value. Each individual capture of the triplicate 12-lead ECG set was separated by 1 to 5 minutes between the first and the third ECG. Screening and post-dose 12-lead ECG measurements were single measurements. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
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|
|
| Secondary | Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Blood samples were collected for analyzing absolute values of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Giga cells per liter | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count | Blood samples were collected for analyzing absolute values of red blood cell (RBC) and reticulocytes count. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Trillion cells per liter | On Day -1 (admission) and Day 5 (Discharge) |
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|
|
| Secondary | Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) | Blood samples were collected for analyzing absolute values of Mean Corpuscular Volume (MCV). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Femtoliters | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Blood samples were collected for analyzing absolute values of Mean corpuscular hemoglobin (MCH). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Picograms | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values of Hematology Parameter: Hemoglobin | Blood samples were collected for analyzing absolute values of Hemoglobin. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Grams per Liter | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values of Hematology Parameter: Hematocrit | Blood samples were collected for analyzing absolute values of Hematocrit. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Percentage | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | 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). | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | International units per Liter | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine | Blood samples were collected for analyzing absolute values of direct bilirubin, total bilirubin and Creatinine. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Micromoles per liter | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values of Clinical Chemistry Parameter: Total Protein | Blood samples were collected for analyzing absolute values of Total protein. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Grams per liter | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN) | Blood samples were collected for analyzing absolute values of Calcium, Sodium, Potassium, Blood Urea Nitrogen. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Millimoles per liter | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values for Chemistry Parameter: Glucose | Blood samples were collected for analyzing absolute values of glucose. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
|
|
|
| Secondary | Number of Participants With Urinalysis Parameters by Dipstick Method | Urine samples were collected to assess glucose, ketones, occult blood, protein, urobilinogen and bilirubin by dipstick method. The dipstick test gave results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Results are presented as'(+)' indicating 'equivocal', '+' indicating 'trace amount', '++' indicating 'positive', and 'negative'. | Safety population. Only those participants with data available at specified time points have been analyzed. | Posted | Count of Participants | Participants | On Day -1 (admission) and Day 5 (Discharge) |
|
|
|
| Secondary | Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Blood pressure 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. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury [mmHg] | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
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|
|
| Secondary | Absolute Values of Pulse Rate | 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. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (Pre-dose at Day 1 and Day 4); 0.25, 0.5, 1 hour (h), 1.5 h, 2 h, 4 h post-dose at Day 1 and Day 4 |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 6 |
| 28 |
| EG001 | Salbutamol HFA-134a MDI | Healthy participants received a single dose of 800 µg (8 x 100 µg dose at 20-second intervals) Salbutamol HFA-134a MDI suspension as inhalation on Day 1 or Day 4 (in either treatment Period 1 or 2). | 0 | 27 | 0 | 27 | 8 | 27 |
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA v26.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| PR, Day 1, 15 min post-dose |
|
|
| PR, Day 1, 30 min post-dose |
|
|
| PR, Day 1, 1 h post-dose |
|
|
| PR, Day 1, 1.5 h post-dose |
|
|
| PR, Day 1, 2 h post-dose |
|
|
| PR, Day 1, 4 h post-dose |
|
|
| PR, Baseline (Day 4, Predose) |
|
|
| PR, Day 4, 15 min post-dose |
|
|
| PR, Day 4, 30 min post-dose |
|
|
| PR, Day 4, 1 h post-dose |
|
|
| PR, Day 4, 1.5 h post-dose |
|
|
| PR, Day 4, 2 h post-dose |
|
|
| PR, Day 4, 4 h post-dose |
|
|
| QRS duration, Baseline (Day 1, Predose) |
|
|
| QRS duration, Day 1, 15 min post-dose |
|
|
| QRS duration, Day 1, 30 min post-dose |
|
|
| QRS duration, Day 1, 1 h post-dose |
|
|
| QRS duration, Day 1, 1.5 h post-dose |
|
|
| QRS duration, Day 1, 2 h post-dose |
|
|
| QRS duration, Day 1, 4 h post-dose |
|
|
| QRS duration, Baseline (Day 4, Predose) |
|
|
| QRS duration, Day 4, 15 min post-dose |
|
|
| QRS duration, Day 4, 30 min post-dose |
|
|
| QRS duration, Day 4, 1 h post-dose |
|
|
| QRS duration, Day 4, 1.5 h post-dose |
|
|
| QRS duration, Day 4, 2 h post-dose |
|
|
| QRS duration, Day 4, 4 h post-dose |
|
|
| QT interval, Baseline (Day 1, Predose) |
|
|
| QT interval, Day 1, 15 min post-dose |
|
|
| QT interval, Day 1, 30 min post-dose |
|
|
| QT interval, Day 1, 1 h post-dose |
|
|
| QT interval, Day 1, 1.5 h post-dose |
|
|
| QT interval, Day 1, 2 h post-dose |
|
|
| QT interval, Day 1, 4 h post-dose |
|
|
| QT interval, Baseline (Day 4, Predose) |
|
|
| QT interval, Day 4, 15 min post-dose |
|
|
| QT interval, Day 4, 30 min post-dose |
|
|
| QT interval, Day 4, 1 h post-dose |
|
|
| QT interval, Day 4, 1.5 h post-dose |
|
|
| QT interval, Day 4, 2 h post-dose |
|
|
| QT interval, Day 4, 4 h post-dose |
|
|
| QTc interval, Baseline (Day 1, Predose) |
|
|
| QTc interval, Day 1, 15 min post-dose |
|
|
| QTc interval, Day 1, 30 min post-dose |
|
|
| QTc interval, Day 1, 1 h post-dose |
|
|
| QTc interval, Day 1, 1.5 h post-dose |
|
|
| QTc interval, Day 1, 2 h post-dose |
|
|
| QTc interval, Day 1, 4 h post-dose |
|
|
| QTc interval, Baseline (Day 4, Predose) |
|
|
| QTc interval, Day 4, 15 min post-dose |
|
|
| QTc interval, Day 4, 30 min post-dose |
|
|
| QTc interval, Day 4, 1 h post-dose |
|
|
| QTc interval, Day 4, 1.5 h post-dose |
|
|
| QTc interval, Day 4, 2 h post-dose |
|
|
| QTc interval, Day 4, 4 h post-dose |
|
|
| PR, CFB to Day 1, 15 min post-dose |
|
|
| PR, CFB to Day 1, 30 min post-dose |
|
|
| PR, CFB to Day 1, 1 h post-dose |
|
|
| PR, CFB to Day 1, 1.5 h post-dose |
|
|
| PR, CFB to Day 1, 2 h post-dose |
|
|
| PR, CFB to Day 1, 4 h post-dose |
|
|
| PR, Baseline (Day 4, Predose) |
|
|
| PR, CFB to Day 4, 15 min post-dose |
|
|
| PR, CFB to Day 4, 30 min post-dose |
|
|
| PR, CFB to Day 4, 1 h post-dose |
|
|
| PR, CFB to Day 4, 1.5 h post-dose |
|
|
| PR, CFB to Day 4, 2 h post-dose |
|
|
| PR, CFB to Day 4, 4 h post-dose |
|
|
| QRS duration, Baseline (Day 1, Predose) |
|
|
| QRS duration, CFB to Day 1, 15 min post-dose |
|
|
| QRS duration, CFB to Day 1, 30 min post-dose |
|
|
| QRS duration, CFB to Day 1, 1 h post-dose |
|
|
| QRS duration, CFB to Day 1, 1.5 h post-dose |
|
|
| QRS duration, CFB to Day 1, 2 h post-dose |
|
|
| QRS duration, CFB to Day 1, 4 h post-dose |
|
|
| QRS duration, Baseline (Day 4, Predose) |
|
|
| QRS duration, CFB to Day 4, 15 min post-dose |
|
|
| QRS duration, CFB to Day 4, 30 min post-dose |
|
|
| QRS duration, CFB to Day 4, 1 h post-dose |
|
|
| QRS duration, CFB to Day 4, 1.5 h post-dose |
|
|
| QRS duration, CFB to Day 4, 2 h post-dose |
|
|
| QRS duration, CFB to Day 4, 4 h post-dose |
|
|
| QT interval, Baseline (Day 1, Predose) |
|
|
| QT interval, CFB to Day 1, 15 min post-dose |
|
|
| QT interval, CFB to Day 1, 30 min post-dose |
|
|
| QT interval, CFB to Day 1, 1 h post-dose |
|
|
| QT interval, CFB to Day 1, 1.5 h post-dose |
|
|
| QT interval, CFB to Day 1, 2 h post-dose |
|
|
| QT interval, CFB to Day 1, 4 h post-dose |
|
|
| QT interval, Baseline (Day 4, Predose) |
|
|
| QT interval, CFB to Day 4, 15 min post-dose |
|
|
| QT interval, CFB to Day 4, 30 min post-dose |
|
|
| QT interval, CFB to Day 4, 1 h post-dose |
|
|
| QT interval, CFB to Day 4, 1.5 h post-dose |
|
|
| QT interval, CFB to Day 4, 2 h post-dose |
|
|
| QT interval, CFB to Day 4, 4 h post-dose |
|
|
| QTc interval, Baseline (Day 1, Predose) |
|
|
| QTc interval, CFB to Day 1, 15 min post-dose |
|
|
| QTc interval, CFB to Day 1, 30 min post-dose |
|
|
| QTc interval, CFB to Day 1, 1 h post-dose |
|
|
| QTc interval, CFB to Day 1, 1.5 h post-dose |
|
|
| QTc interval, CFB to Day 1, 2 h post-dose |
|
|
| QTc interval, CFB to Day 1, 4 h post-dose |
|
|
| QTc interval, Baseline (Day 4, Predose) |
|
|
| QTc interval, CFB to Day 4, 15 min post-dose |
|
|
| QTc interval, CFB to Day 4, 30 min post-dose |
|
|
| QTc interval, CFB to Day 4, 1 h post-dose |
|
|
| QTc interval, CFB to Day 4, 1.5 h post-dose |
|
|
| QTc interval, CFB to Day 4, 2 h post-dose |
|
|
| QTc interval, CFB to Day 4, 4 h post-dose |
|
|
| Day 1, 15 min post-dose |
|
|
| Day 1, 30 min post-dose |
|
|
| Day 1, 1 h post-dose |
|
|
| Day 1, 1.5 h post-dose |
|
|
| Day 1, 2 h post-dose |
|
|
| Day 1, 4 h post-dose |
|
|
| Baseline (Day 4, Predose) |
|
|
| Day 4, 15 min post-dose |
|
|
| Day 4, 30 min post-dose |
|
|
| Day 4, 1 h post-dose |
|
|
| Day 4, 1.5 h post-dose |
|
|
| Day 4, 2 h post-dose |
|
|
| Day 4, 4 h post-dose |
|
|
| CFB Day 1, 15 min post-dose |
|
|
| CFB Day 1, 30 min post-dose |
|
|
| CFB Day 1, 1 h post-dose |
|
|
| CFB Day 1, 1.5 h post-dose |
|
|
| CFB Day 1, 2 h post-dose |
|
|
| CFB Day 1, 4 h post-dose |
|
|
| Baseline (Day 4, Predose) |
|
|
| CFB Day 4, 15 min post-dose |
|
|
| CFB Day 4, 30 min post-dose |
|
|
| CFB Day 4, 1 h post-dose |
|
|
| CFB Day 4, 1.5 h post-dose |
|
|
| CFB Day 4, 2 h post-dose |
|
|
| CFB Day 4, 4 h post-dose |
|
|
| Basophils, Day 5 |
|
|
| Eosinophils, Day -1 |
|
|
| Eosinophils, Day 5 |
|
|
| Lymphocytes, Day -1 |
|
|
| Lymphocytes, Day 5 |
|
|
| Monocytes, Day -1 |
|
|
| Monocytes, Day 5 |
|
|
| Neutrophils, Day -1 |
|
|
| Neutrophils, Day 5 |
|
|
| Platelet count, Day -1 |
|
|
| Platelet count, Day 5 |
|
|
| RBC, Day 5 |
|
|
| Reticulocytes, Day -1 |
|
|
| Reticulocytes, Day 5 |
|
|
| Day 5 |
|
|
| Day 5 |
|
|
| Day 5 |
|
|
| Day 5 |
|
|
| ALT, Day 5 |
|
|
| ALP, Day -1 |
|
|
| ALP, Day 5 |
|
|
| AST, Day -1 |
|
|
| AST, Day 5 |
|
|
| CPK, Day -1 |
|
|
| CPK, Day 5 |
|
|
| Direct Bilirubin, Day 5 |
|
|
| Total Bilirubin, Day -1 |
|
|
| Total Bilirubin, Day 5 |
|
|
| Creatinine, Day -1 |
|
|
| Creatinine, Day 5 |
|
|
| Day 5 |
|
|
| Calcium, Day 5 |
|
|
| Sodium, Day -1 |
|
|
| Sodium, Day 5 |
|
|
| BUN, Day -1 |
|
|
| BUN, Day 5 |
|
|
| Day 1, 15 min post-dose |
|
|
| Day 1, 30 min post-dose |
|
|
| Day 1, 1 h post-dose |
|
|
| Day 1, 1.5 h post-dose |
|
|
| Day 1, 2 h post-dose |
|
|
| Day 1, 4 h post-dose |
|
|
| Baseline (Day 4, Predose) |
|
|
| Day 4, 15 min post-dose |
|
|
| Day 4, 30 min post-dose |
|
|
| Day 4, 1 h post-dose |
|
|
| Day 4, 1.5 h post-dose |
|
|
| Day 4, 2 h post-dose |
|
|
| Day 4, 4 h post-dose |
|
|
| + |
|
| ++ |
|
| Negative |
|
| Urine Protein, Day 5 |
|
|
| Urine Glucose, Day -1 |
|
|
| Urine Glucose, Day 5 |
|
|
| Ketones, Day -1 |
|
|
| Ketones, Day 5 |
|
|
| Urine Hemoglobin, Day -1 |
|
|
| Urine Hemoglobin, Day 5 |
|
|
| DBP, Day 1, 15 min post-dose |
|
|
| DBP, Day 1, 30 min post-dose |
|
|
| DBP, Day 1, 1 h post-dose |
|
|
| DBP, Day 1, 1.5 h post-dose |
|
|
| DBP, Day 1, 2 h post-dose |
|
|
| DBP, Day 1, 4 h post-dose |
|
|
| DBP, Baseline (Day 4, Predose) |
|
|
| DBP, Day 4, 15 min post-dose |
|
|
| DBP, Day 4, 30 min post-dose |
|
|
| DBP, Day 4, 1 h post-dose |
|
|
| DBP, Day 4, 1.5 h post-dose |
|
|
| DBP, Day 4, 2 h post-dose |
|
|
| DBP, Day 4, 4 h post-dose |
|
|
| SBP, Baseline (Day 1, Predose) |
|
|
| SBP, Day 1, 15 min post-dose |
|
|
| SBP, Day 1, 30 min post-dose |
|
|
| SBP, Day 1, 1 h post-dose |
|
|
| SBP, Day 1, 1.5 h post-dose |
|
|
| SBP, Day 1, 2 h post-dose |
|
|
| SBP, Day 1, 4 h post-dose |
|
|
| SBP, Baseline (Day 4, Predose) |
|
|
| SBP, Day 4, 15 min post-dose |
|
|
| SBP, Day 4, 30 min post-dose |
|
|
| SBP, Day 4, 1 h post-dose |
|
|
| SBP, Day 4, 1.5 h post-dose |
|
|
| SBP, Day 4, 2 h post-dose |
|
|
| SBP, Day 4, 4 h post-dose |
|
|
| Day 1, 15 min post-dose |
|
|
| Day 1, 30 min post-dose |
|
|
| Day 1, 1 h post-dose |
|
|
| Day 1, 1.5 h post-dose |
|
|
| Day 1, 2 h post-dose |
|
|
| Day 1, 4 h post-dose |
|
|
| Baseline (Day 4, Predose) |
|
|
| Day 4, 15 min post-dose |
|
|
| Day 4, 30 min post-dose |
|
|
| Day 4, 1 h post-dose |
|
|
| Day 4, 1.5 h post-dose |
|
|
| Day 4, 2 h post-dose |
|
|
| Day 4, 4 h post-dose |
|
|