Bioequivalence Study Between GR37547 500 Milligrams (mg)... | NCT03150082

Status Module

Name	Class
Parexel	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment sequence: A/B	Experimental	Eligible subjects will be randomized to receive a single dose of Treatment A (GR37547 500 mg tablet) followed by Treatment B (ciprofloxacin 500 mg reference tablet) administered orally on Day 1 in each treatment period. The washout period will be of at least 7 days and not more than 14 days.	Drug: GR37547 tablet Drug: Ciprofloxacin reference tablet
Treatment sequence: B/A	Experimental	Eligible subjects will be randomized to receive a single dose of Treatment B (ciprofloxacin 500 mg reference tablet) followed by Treatment A (GR37547 500 mg tablet) administered orally. The washout period will be of at least 7 days and not more than 14 days.	Drug: GR37547 tablet Drug: Ciprofloxacin reference tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GR37547 tablet	Drug	A single tablet of GR37547 should be taken orally with 240 mL of water. GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed "GSK500"on lower side.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin	Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.	Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period
Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin	Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.	Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin	Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be between 18 and 60 years of age inclusive, at the time of signing the informed consent.
Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required,agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 19-30 kg per meter square (kg/m^2) (inclusive).
Healthy Male or female subjects: Male subjects: A male subject must agree to use contraception during the treatment period and for at least 5 days, after the last dose of study treatment and refrain from donating sperm during this period; Female subjects: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.
The investigator is responsible for ensuring that male and female study subjects understand how to correctly use the methods of contraception.
Capable of giving signed informed consent.

Exclusion Criteria:

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neuromuscular, psychiatric, auto-immune or neurological disorders.
History of convulsions.
Any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
History of any malignancies or chemotherapy/radiation within the past 5 years excluding treated squamous carcinoma of the skin and adequately excised basal cell carcinoma.
History of kidney, heart or lung transplants.
History or presence of rheumatoid arthritis.
Presence of hypocalcaemia where the serum potassium is < lower limit of normal (LLN).
Presence of hypomagnesaemia where the serum magnesium is < LLN.
Fasting blood glucose >=7 millimoles (mmol)/liter (L).
Serum glucose-6-phosphate dehydrogenase < LLN.
Abnormal renal function, as determined by creatinine clearance and considered as clinically significant by the investigator will be excluded.
Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Excessive alkalinity of the urine (potential of hydrogen [pH] >=9), as determined on Day -1.
Abnormal BP as determined by the investigator.
QT interval corrected for heart rate according to Bazett's formula (QTcB) >450 milliseconds (msec). Subjects with a known risk of QT prolongation will be excluded. For purposes of data analysis, only QTcB, will be used
Past or intended use of over-the-counter or prescription medication including herbal medications, within 14 days prior to dosing unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
Where participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 90 days.
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
Current enrolment or past participation within the last 90 days before signing of consent in this or any other clinical study involving an investigational study treatment.
Presence of Hepatitis B surface antigen (HBsAg) at screening or a Positive Hepatitis C antibody test result at screening.
Positive pre-study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
Regular use of known drugs of abuse.
Sensitivity to heparin or heparin-induced thrombocytopenia.
Sensitivity to any of the study treatments, or components thereof, or drug or other allergy including allergy to quinolones that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco or nicotine-containing products within 6 months prior to screening.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bloemfontein		9301	South Africa

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GR37547 Followed by Ciprofloxacin Reference Product	Eligible participants received a single dose of Treatment A (GR37547 500 mg tablet), administered orally on Day 1 in treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received Treatment B (ciprofloxacin 500 mg reference tablet), administered orally on Day 1 in treatment period 2.

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_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 11, 2017

ID	Title	Description
BG000	All Participants	Eligible participants received a single dose of Treatment A (GR37547 500 mg tablet) followed by Treatment B (ciprofloxacin 500 mg reference tablet) or vice versa, administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants	BG00026

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 From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour*nanogram per milliliter

Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period

ID	Title	Description
OG000	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants	OG00025 OG00125

Title

Denominators

Categories

Title	Measurements
	OG00011600± 22.5 OG00111300± 27.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Percent ratio	96.88			2-Sided	90	91.13	103.00			Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.		Equivalence	Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.

Primary

Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter

Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period

ID	Title	Description
OG000	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour*nanogram per milliliter

Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period

ID	Title	Description
OG000	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Time of Occurrence of Cmax (Tmax) for Ciprofloxacin

Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of ciprofloxacin was analyzed using a nonparametric test to compute point estimate of the median and full range.

Pharmacokinetic Population

Posted

Median

Full Range

Hours

Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period

ID	Title	Description
OG000	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Percentage of AUCex

Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period

ID	Title	Description
OG000	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Terminal Phase Half-life (t1/2) for Ciprofloxacin

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period

ID	Title	Description
OG000	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-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. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.

Safety Population

Posted

Number

Participants

Up to 4 weeks in each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Secondary

Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, Alk phos, AST and LD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Units per liter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts

Secondary

Blood Urea Nitrogen (BUN) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Milligrams per deciliter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, chloride, glucose, magnesium, potassium and sodium. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Millimoles per liter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts

Secondary

Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Moles per liter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts

Secondary

Total Protein at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Grams per liter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

10^9 cells per liter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units

Secondary

Mean Corpuscular Volume (MCV) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Femtoliter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Picogram

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Grams per deciliter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Percent Reticulocytes at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Percentage of reticulocytes

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Hematocrit at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Proportion of red blood cells in blood

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Erythrocyte Count at Indicated Time-points

Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

10^12 cells per liter

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Abnormal Findings for Urinalysis

Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. The number of participants with abnormal (clinically significant) findings for urinalysis have been presented.

Safety Population

Posted

Number

Participants

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters

A single 12-lead ECGs was obtained on Day 1 and Day 2 of each treatment period 1 and 2 using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. The number of participants with abnormal (clinically significant) findings for ECG parameters have been presented.

Safety Population

Posted

Number

Participants

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts

Secondary

Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points

Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Millimeters of mercury

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Respiratory Rate at Indicated Time-points

Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Breaths per minute

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Pulse Rate at Indicated Time-points

Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Beats per minute

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Secondary

Body Temperature at Indicated Time-points

Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Safety Population

Posted

Mean

Standard Deviation

Degree Celsius

Up to Day 2 of each treatment period

ID	Title	Description
OG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
OG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.

Units	Counts
Participants

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected26 at risk EG0011 affected25 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected26 at risk EG0010 affected25 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected26 at risk EG0010 affected25 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected26 at risk EG0011 affected25 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected26 at risk EG0012 affected25 at risk
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected26 at risk EG0011 affected25 at risk
Somnolence	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected26 at risk EG0011 affected25 at risk

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GR37547 500 mg	Eligible participants received GR37547 ciprofloxacin 500 mg tablet test product (Treatment A), administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.	0	26	0	26	6	26
EG001	Ciprofloxacin 500 mg Reference	Eligible participants received ciprofloxacin 500 mg tablet reference product (Treatment B) , administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.	0	25	0	25	6	25