Trial Outcomes & Findings for Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects (NCT NCT03150082)
NCT ID: NCT03150082
Last Updated: 2018-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
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
Results posted on
2018-12-19
Participant Flow
This was an open-label, randomized, single-dose, two-period cross-over study to evaluate bioequivalence of GR37547 ciprofloxacin 500 milligrams (mg) test product versus ciprofloxacin 500 mg reference product in healthy adult participants under fasting conditions. Participants were enrolled at a single center in South Africa.
Participants received treatment in one of the two sequences; Treatment A (GR37547) followed by Treatment B (ciprofloxacin reference) or vice versa in each of the treatment period 1 and 2. A total number of 26 participants were randomized.
Participant milestones
| Measure |
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.
|
Ciprofloxacin Reference Product Followed by GR37547
Eligible participants received Treatment B (ciprofloxacin 500 mg reference 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 a single dose of Treatment A (GR37547 500 mg tablet), administered orally on Day 1 in treatment period 2.
|
|---|---|---|
|
Treatment Period 1 (Up to 4 Weeks)
STARTED
|
13
|
13
|
|
Treatment Period 1 (Up to 4 Weeks)
COMPLETED
|
12
|
13
|
|
Treatment Period 1 (Up to 4 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Washout Period (Up to 4 Weeks)
STARTED
|
12
|
13
|
|
Washout Period (Up to 4 Weeks)
COMPLETED
|
12
|
13
|
|
Washout Period (Up to 4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (Up to 4 Weeks)
STARTED
|
12
|
13
|
|
Treatment Period 2 (Up to 4 Weeks)
COMPLETED
|
12
|
13
|
|
Treatment Period 2 (Up to 4 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Ciprofloxacin Reference Product Followed by GR37547
Eligible participants received Treatment B (ciprofloxacin 500 mg reference 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 a single dose of Treatment A (GR37547 500 mg tablet), administered orally on Day 1 in treatment period 2.
|
|---|---|---|
|
Treatment Period 1 (Up to 4 Weeks)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
All Participants
n=26 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.
|
|---|---|
|
Age, Continuous
|
23.5 Years
STANDARD_DEVIATION 5.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White -White/Caucasian/European Heritage
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other-Mixed Race
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=25 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
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
|
11600 Hour*nanogram per milliliter
Geometric Coefficient of Variation 22.5
|
11300 Hour*nanogram per milliliter
Geometric Coefficient of Variation 27.7
|
PRIMARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=25 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin
|
3140 Nanogram per milliliter
Geometric Coefficient of Variation 21.6
|
2940 Nanogram per milliliter
Geometric Coefficient of Variation 29.6
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=25 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin
|
12000 Hour*nanogram per milliliter
Geometric Coefficient of Variation 22.0
|
11600 Hour*nanogram per milliliter
Geometric Coefficient of Variation 27.3
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=25 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Time of Occurrence of Cmax (Tmax) for Ciprofloxacin
|
1.253 Hours
Interval 0.5 to 2.0
|
1.009 Hours
Interval 0.5 to 2.52
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=25 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin
|
2.83 Percentage of AUCex
Geometric Coefficient of Variation 31.6
|
2.85 Percentage of AUCex
Geometric Coefficient of Variation 36.9
|
SECONDARY outcome
Timeframe: 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 periodPopulation: Pharmacokinetic Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=25 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Terminal Phase Half-life (t1/2) for Ciprofloxacin
|
5.02 Hours
Geometric Coefficient of Variation 13.5
|
4.82 Hours
Geometric Coefficient of Variation 19.8
|
SECONDARY outcome
Timeframe: Up to 4 weeks in each treatment periodPopulation: Safety Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs)
Any Non-SAE
|
6 Participants
|
6 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
ALT; Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
17.3 Units per liter
Standard Deviation 10.50
|
18.0 Units per liter
Standard Deviation 10.85
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
ALT; Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
15.3 Units per liter
Standard Deviation 8.74
|
16.4 Units per liter
Standard Deviation 12.71
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
ALT; Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
21.2 Units per liter
Standard Deviation 22.95
|
16.6 Units per liter
Standard Deviation 10.75
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
ALT; Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
20.8 Units per liter
Standard Deviation 28.51
|
14.6 Units per liter
Standard Deviation 9.41
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
Alk Phos;Period 1;Day -1,24 Hours Pre-dose;n=13,13
|
72.7 Units per liter
Standard Deviation 21.83
|
65.5 Units per liter
Standard Deviation 15.69
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
Alk Phos;Period 1;Day 2,24 Hours Post-dose;n=13,13
|
67.6 Units per liter
Standard Deviation 22.88
|
61.0 Units per liter
Standard Deviation 15.02
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
Alk Phos;Period 2;Day -1,24 Hours Pre-dose;n=13,12
|
63.8 Units per liter
Standard Deviation 15.66
|
74.9 Units per liter
Standard Deviation 22.51
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
Alk Phos;Period 2;Day 2,24 Hours Post-dose;n=13,12
|
59.4 Units per liter
Standard Deviation 13.48
|
70.3 Units per liter
Standard Deviation 23.59
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
AST; Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
21.3 Units per liter
Standard Deviation 6.82
|
20.8 Units per liter
Standard Deviation 3.39
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
AST; Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
18.2 Units per liter
Standard Deviation 4.51
|
17.5 Units per liter
Standard Deviation 3.67
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
AST; Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
22.6 Units per liter
Standard Deviation 8.83
|
21.2 Units per liter
Standard Deviation 8.79
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
AST; Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
19.4 Units per liter
Standard Deviation 7.40
|
18.3 Units per liter
Standard Deviation 5.73
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
LD; Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
324.9 Units per liter
Standard Deviation 57.56
|
322.2 Units per liter
Standard Deviation 56.71
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
LD; Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
280.6 Units per liter
Standard Deviation 47.22
|
273.9 Units per liter
Standard Deviation 46.00
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
LD; Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
331.4 Units per liter
Standard Deviation 49.08
|
327.0 Units per liter
Standard Deviation 54.87
|
|
Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points
LD; Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
287.2 Units per liter
Standard Deviation 52.27
|
291.8 Units per liter
Standard Deviation 43.00
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Blood Urea Nitrogen (BUN) at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
11.322 Milligrams per deciliter
Standard Deviation 3.810
|
10.392 Milligrams per deciliter
Standard Deviation 2.201
|
|
Blood Urea Nitrogen (BUN) at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
10.909 Milligrams per deciliter
Standard Deviation 2.611
|
10.073 Milligrams per deciliter
Standard Deviation 1.510
|
|
Blood Urea Nitrogen (BUN) at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
11.444 Milligrams per deciliter
Standard Deviation 3.133
|
11.682 Milligrams per deciliter
Standard Deviation 2.241
|
|
Blood Urea Nitrogen (BUN) at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
10.548 Milligrams per deciliter
Standard Deviation 1.674
|
11.583 Milligrams per deciliter
Standard Deviation 1.860
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Calcium;Period 2;Day -1, 24 Hours Pre-dose;n=13,12
|
2.335 Millimoles per liter
Standard Deviation 0.103
|
2.348 Millimoles per liter
Standard Deviation 0.059
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Calcium;Period 2;Day 2, 24 Hours Post-dose;n=13,12
|
2.265 Millimoles per liter
Standard Deviation 0.069
|
2.309 Millimoles per liter
Standard Deviation 0.076
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Chloride;Period 2;Day 2,24 Hours Post-dose;n=13,12
|
107.22 Millimoles per liter
Standard Deviation 1.213
|
106.68 Millimoles per liter
Standard Deviation 1.471
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Magnesium;Period 1;Day2, 24Hours Post-dose;n=13,13
|
0.813 Millimoles per liter
Standard Deviation 0.054
|
0.828 Millimoles per liter
Standard Deviation 0.039
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Magnesium;Period 2;Day -1,24Hours Pre-dose;n=13,12
|
0.800 Millimoles per liter
Standard Deviation 0.055
|
0.809 Millimoles per liter
Standard Deviation 0.075
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Magnesium;Period 2;Day 2,24Hours Post-dose;n=13,12
|
0.836 Millimoles per liter
Standard Deviation 0.048
|
0.841 Millimoles per liter
Standard Deviation 0.048
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Potassium;Period 1;Day -1,24Hours Pre-dose;n=13,13
|
4.431 Millimoles per liter
Standard Deviation 0.335
|
4.450 Millimoles per liter
Standard Deviation 0.251
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Potassium;Period 1;Day 2,24Hours Post-dose;n=13,13
|
4.511 Millimoles per liter
Standard Deviation 0.283
|
4.349 Millimoles per liter
Standard Deviation 0.248
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Sodium;Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
140.15 Millimoles per liter
Standard Deviation 2.304
|
139.85 Millimoles per liter
Standard Deviation 2.478
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Sodium; Period 1;Day 2, 24 Hours Post-dose;n=13,13
|
141.46 Millimoles per liter
Standard Deviation 1.506
|
141.62 Millimoles per liter
Standard Deviation 1.502
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Sodium;Period 2; Day -1,24 Hours Pre-dose;n=13,12
|
138.54 Millimoles per liter
Standard Deviation 1.561
|
139.00 Millimoles per liter
Standard Deviation 1.809
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Chloride;Period 1;Day -1,24Hours Pre-dose;n=13,13
|
104.41 Millimoles per liter
Standard Deviation 2.077
|
104.38 Millimoles per liter
Standard Deviation 1.305
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Chloride;Period 1;Day 2,24 Hours Post-dose;n=13,13
|
106.29 Millimoles per liter
Standard Deviation 1.715
|
106.68 Millimoles per liter
Standard Deviation 1.392
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Chloride;Period 2;Day -1,24 Hours Pre-dose;n=13,12
|
103.65 Millimoles per liter
Standard Deviation 1.975
|
103.74 Millimoles per liter
Standard Deviation 1.641
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Calcium;Period 1;Day -1,24 Hours Pre-dose;n=13,13
|
2.354 Millimoles per liter
Standard Deviation 0.072
|
2.337 Millimoles per liter
Standard Deviation 0.088
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Calcium;Period 1;Day 2, 24 Hours Post-dose;n=13,13
|
2.269 Millimoles per liter
Standard Deviation 0.082
|
2.250 Millimoles per liter
Standard Deviation 0.081
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Glucose;Period 1; Day -1,24 Hours Pre-dose;n=13,13
|
4.691 Millimoles per liter
Standard Deviation 0.260
|
4.666 Millimoles per liter
Standard Deviation 0.312
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Glucose;Period 1; Day 2,24 Hours Post-dose;n=13,13
|
4.738 Millimoles per liter
Standard Deviation 0.272
|
4.669 Millimoles per liter
Standard Deviation 0.191
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Glucose;Period 2;Day -1,24 Hours Pre-dose;n=13,12
|
4.377 Millimoles per liter
Standard Deviation 0.238
|
4.696 Millimoles per liter
Standard Deviation 0.381
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Glucose;Period 2;Day 2,24 Hours Post-dose;n=13,12
|
4.508 Millimoles per liter
Standard Deviation 0.235
|
4.608 Millimoles per liter
Standard Deviation 0.255
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Magnesium;Period 1;Day -1,24Hours Pre-dose;n=13,13
|
0.830 Millimoles per liter
Standard Deviation 0.052
|
0.823 Millimoles per liter
Standard Deviation 0.043
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Potassium;Period 2;Day -1,24Hours Pre-dose;n=13,12
|
4.518 Millimoles per liter
Standard Deviation 0.339
|
4.581 Millimoles per liter
Standard Deviation 0.317
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Potassium;Period 2;Day 2,24Hours Post-dose;n=13,12
|
4.341 Millimoles per liter
Standard Deviation 0.218
|
4.570 Millimoles per liter
Standard Deviation 0.338
|
|
Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points
Sodium; Period 2;Day 2, 24 Hours Post-dose;n=13,12
|
140.62 Millimoles per liter
Standard Deviation 1.325
|
140.92 Millimoles per liter
Standard Deviation 1.443
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Direct bil;Period2;Day-1,24Hours Pre-dose;n=13,12
|
3.50 Moles per liter
Standard Deviation 1.477
|
3.40 Moles per liter
Standard Deviation 1.285
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Direct bil;Period2;Day 2,24Hours Post-dose;n=13,12
|
3.12 Moles per liter
Standard Deviation 1.336
|
2.90 Moles per liter
Standard Deviation 0.932
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Creat; Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
79.2 Moles per liter
Standard Deviation 12.33
|
75.2 Moles per liter
Standard Deviation 18.15
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Creat; Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
71.6 Moles per liter
Standard Deviation 15.61
|
74.8 Moles per liter
Standard Deviation 13.13
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Creat Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
73.4 Moles per liter
Standard Deviation 17.16
|
76.8 Moles per liter
Standard Deviation 12.62
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Total bil;Period 1;Day -1,24Hours Pre-dose;n=13,13
|
9.39 Moles per liter
Standard Deviation 2.415
|
9.05 Moles per liter
Standard Deviation 5.429
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Total bil;Period 1;Day 2,24Hours Post-dose;n=13,13
|
8.18 Moles per liter
Standard Deviation 3.176
|
7.88 Moles per liter
Standard Deviation 4.556
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Total bil;Period 2;Day -1,24Hours Pre-dose;n=13,12
|
9.29 Moles per liter
Standard Deviation 5.012
|
8.78 Moles per liter
Standard Deviation 4.888
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Total bil;Period 2;Day 2,24Hours Post-dose;n=13,12
|
8.10 Moles per liter
Standard Deviation 4.383
|
6.90 Moles per liter
Standard Deviation 3.207
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Direct bil;Period 1;Day-1,24Hours Pre-dose;n=13,13
|
3.89 Moles per liter
Standard Deviation 0.779
|
3.46 Moles per liter
Standard Deviation 1.693
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Direct bil;Period 1;Day2,24Hours Post-dose;n=13,13
|
3.14 Moles per liter
Standard Deviation 0.965
|
2.87 Moles per liter
Standard Deviation 1.297
|
|
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Creat; Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
76.3 Moles per liter
Standard Deviation 11.24
|
72.2 Moles per liter
Standard Deviation 17.22
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Total Protein at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
70.32 Grams per liter
Standard Deviation 5.023
|
68.82 Grams per liter
Standard Deviation 4.013
|
|
Total Protein at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose ;n=13,12
|
73.31 Grams per liter
Standard Deviation 4.296
|
76.51 Grams per liter
Standard Deviation 4.268
|
|
Total Protein at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose ;n=13,12
|
70.23 Grams per liter
Standard Deviation 2.985
|
72.06 Grams per liter
Standard Deviation 2.831
|
|
Total Protein at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
75.45 Grams per liter
Standard Deviation 5.090
|
74.58 Grams per liter
Standard Deviation 3.093
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Eosinophils;Period1;Day2,24Hours Post-dose;n=13,13
|
0.209 10^9 cells per liter
Standard Deviation 0.186
|
0.128 10^9 cells per liter
Standard Deviation 0.060
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Eosinophils;Period2;Day-1,24Hours Pre-dose;n=13,12
|
0.127 10^9 cells per liter
Standard Deviation 0.068
|
0.286 10^9 cells per liter
Standard Deviation 0.259
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Leucocyte;Period 2;Day-1,24Hours Pre-dose;n=13,12
|
6.373 10^9 cells per liter
Standard Deviation 1.577
|
5.508 10^9 cells per liter
Standard Deviation 1.246
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Lymphocytes;Period1;Day -1,24Hours Predose;n=13,13
|
1.885 10^9 cells per liter
Standard Deviation 0.430
|
2.215 10^9 cells per liter
Standard Deviation 0.596
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Monocytes;Period 2;Day -1,24Hours Pre-dose;n=13,12
|
0.560 10^9 cells per liter
Standard Deviation 0.167
|
0.519 10^9 cells per liter
Standard Deviation 0.166
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Neutrophil;Period1;Day -1,24Hours Pre-dose;n=13,13
|
2.622 10^9 cells per liter
Standard Deviation 1.130
|
3.012 10^9 cells per liter
Standard Deviation 1.225
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Neutrophil;Period1;Day 2,24Hours Post-dose;n=13,13
|
2.424 10^9 cells per liter
Standard Deviation 1.393
|
2.602 10^9 cells per liter
Standard Deviation 1.226
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Neutrophil;Period2;Day -1,24Hours Pre-dose;n=13,12
|
3.100 10^9 cells per liter
Standard Deviation 1.154
|
2.469 10^9 cells per liter
Standard Deviation 0.774
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Platelets;Period 1;Day 2,24Hours Post-dose;n=13,13
|
295.1 10^9 cells per liter
Standard Deviation 63.24
|
281.5 10^9 cells per liter
Standard Deviation 62.29
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Platelets;Period 2;Day 2,24Hours Post-dose;n=13,12
|
296.5 10^9 cells per liter
Standard Deviation 72.54
|
299.9 10^9 cells per liter
Standard Deviation 65.97
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Basophils;Period 1;Day -1,24Hours Pre-dose;n=13,13
|
0.032 10^9 cells per liter
Standard Deviation 0.020
|
0.022 10^9 cells per liter
Standard Deviation 0.012
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Basophils;Period1; Day2,24Hours Post-dose ;n=13,13
|
0.031 10^9 cells per liter
Standard Deviation 0.019
|
0.018 10^9 cells per liter
Standard Deviation 0.011
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Basophils;Period 2;Day -1,24Hours Pre-dose;n=13,12
|
0.019 10^9 cells per liter
Standard Deviation 0.012
|
0.033 10^9 cells per liter
Standard Deviation 0.019
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Basophils;Period 2;Day2, 24Hours Post-dose;n=13,12
|
0.019 10^9 cells per liter
Standard Deviation 0.010
|
0.031 10^9 cells per liter
Standard Deviation 0.021
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Eosinophils;Period1;Day-1,24Hours Pre-dose;n=13,13
|
0.237 10^9 cells per liter
Standard Deviation 0.259
|
0.132 10^9 cells per liter
Standard Deviation 0.071
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Eosinophils;Period2;Day2,24Hours Post-dose;n=13,12
|
0.115 10^9 cells per liter
Standard Deviation 0.073
|
0.286 10^9 cells per liter
Standard Deviation 0.271
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Leucocyte;Period 1;Day-1,24Hours Pre-dose;n=13,13
|
5.247 10^9 cells per liter
Standard Deviation 1.509
|
5.915 10^9 cells per liter
Standard Deviation 1.473
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Leucocyte;Period 1;Day 2,24Hours Post-dose;n=13,13
|
4.897 10^9 cells per liter
Standard Deviation 1.232
|
5.269 10^9 cells per liter
Standard Deviation 1.349
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Leucocyte;Period 2;Day 2,24Hours Post-dose;n=13,12
|
5.118 10^9 cells per liter
Standard Deviation 1.159
|
4.973 10^9 cells per liter
Standard Deviation 0.797
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Lymphocytes;Period1;Day2,24Hours Post-dose;n=13,13
|
1.781 10^9 cells per liter
Standard Deviation 0.379
|
2.026 10^9 cells per liter
Standard Deviation 0.555
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Lymphocytes;Period2;Day -1,24Hours Predose;n=13,12
|
2.567 10^9 cells per liter
Standard Deviation 0.641
|
2.201 10^9 cells per liter
Standard Deviation 0.470
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Lymphocytes;Period2;Day2,24Hours Post-dose;n=13,12
|
1.938 10^9 cells per liter
Standard Deviation 0.451
|
1.883 10^9 cells per liter
Standard Deviation 0.310
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Monocytes;Period 1;Day -1,24Hours Pre-dose;n=13,13
|
0.471 10^9 cells per liter
Standard Deviation 0.176
|
0.535 10^9 cells per liter
Standard Deviation 0.124
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Monocytes;Period 1;Day 2,24Hours Post-dose;n=13,13
|
0.452 10^9 cells per liter
Standard Deviation 0.157
|
0.495 10^9 cells per liter
Standard Deviation 0.156
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Monocytes;Period 2;Day 2,24Hours Post-dose;n=13,12
|
0.451 10^9 cells per liter
Standard Deviation 0.134
|
0.443 10^9 cells per liter
Standard Deviation 0.153
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Neutrophil;Period2;Day 2,24Hours Post-dose;n=13,12
|
2.594 10^9 cells per liter
Standard Deviation 0.802
|
2.330 10^9 cells per liter
Standard Deviation 0.575
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Platelets;Period 1;Day -1,24Hours Pre-dose;n=13,13
|
313.4 10^9 cells per liter
Standard Deviation 62.52
|
292.5 10^9 cells per liter
Standard Deviation 71.81
|
|
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Platelets;Period 2;Day -1,24Hours Pre-dose;n=13,12
|
307.6 10^9 cells per liter
Standard Deviation 70.01
|
325.2 10^9 cells per liter
Standard Deviation 77.79
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Mean Corpuscular Volume (MCV) at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
82.95 Femtoliter
Standard Deviation 4.668
|
83.01 Femtoliter
Standard Deviation 4.613
|
|
Mean Corpuscular Volume (MCV) at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
82.88 Femtoliter
Standard Deviation 4.735
|
82.65 Femtoliter
Standard Deviation 4.406
|
|
Mean Corpuscular Volume (MCV) at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
83.42 Femtoliter
Standard Deviation 4.511
|
83.30 Femtoliter
Standard Deviation 4.657
|
|
Mean Corpuscular Volume (MCV) at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
83.21 Femtoliter
Standard Deviation 4.397
|
83.27 Femtoliter
Standard Deviation 4.660
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
29.13 Picogram
Standard Deviation 2.240
|
29.02 Picogram
Standard Deviation 1.940
|
|
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
28.89 Picogram
Standard Deviation 1.870
|
28.88 Picogram
Standard Deviation 2.316
|
|
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
29.05 Picogram
Standard Deviation 2.172
|
28.86 Picogram
Standard Deviation 1.809
|
|
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
28.94 Picogram
Standard Deviation 1.829
|
29.00 Picogram
Standard Deviation 2.324
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
MCHC;Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
34.78 Grams per deciliter
Standard Deviation 0.755
|
34.78 Grams per deciliter
Standard Deviation 1.176
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Hb; Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
14.48 Grams per deciliter
Standard Deviation 1.862
|
14.20 Grams per deciliter
Standard Deviation 1.469
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Hb; Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
13.41 Grams per deciliter
Standard Deviation 1.574
|
13.82 Grams per deciliter
Standard Deviation 1.985
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
MCHC;Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
35.00 Grams per deciliter
Standard Deviation 1.078
|
34.78 Grams per deciliter
Standard Deviation 0.829
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
MCHC;Period 1; Day 2, 24 Hours Post-dose; n=13,13
|
35.12 Grams per deciliter
Standard Deviation 1.083
|
35.09 Grams per deciliter
Standard Deviation 0.852
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
MCHC; Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
34.62 Grams per deciliter
Standard Deviation 0.873
|
34.58 Grams per deciliter
Standard Deviation 1.245
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Hb; Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
14.04 Grams per deciliter
Standard Deviation 1.782
|
13.74 Grams per deciliter
Standard Deviation 1.669
|
|
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Hb; Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
13.88 Grams per deciliter
Standard Deviation 1.499
|
14.23 Grams per deciliter
Standard Deviation 2.119
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Percent Reticulocytes at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
2.277 Percentage of reticulocytes
Standard Deviation 0.442
|
2.069 Percentage of reticulocytes
Standard Deviation 0.250
|
|
Percent Reticulocytes at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
2.085 Percentage of reticulocytes
Standard Deviation 0.369
|
2.123 Percentage of reticulocytes
Standard Deviation 0.280
|
|
Percent Reticulocytes at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
2.362 Percentage of reticulocytes
Standard Deviation 0.275
|
2.167 Percentage of reticulocytes
Standard Deviation 0.347
|
|
Percent Reticulocytes at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
0.931 Percentage of reticulocytes
Standard Deviation 0.155
|
1.883 Percentage of reticulocytes
Standard Deviation 0.513
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Hematocrit at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
0.400 Proportion of red blood cells in blood
Standard Deviation 0.035
|
0.410 Proportion of red blood cells in blood
Standard Deviation 0.051
|
|
Hematocrit at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
0.385 Proportion of red blood cells in blood
Standard Deviation 0.040
|
0.396 Proportion of red blood cells in blood
Standard Deviation 0.047
|
|
Hematocrit at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
0.399 Proportion of red blood cells in blood
Standard Deviation 0.041
|
0.391 Proportion of red blood cells in blood
Standard Deviation 0.041
|
|
Hematocrit at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
0.413 Proportion of red blood cells in blood
Standard Deviation 0.044
|
0.408 Proportion of red blood cells in blood
Standard Deviation 0.036
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Erythrocyte Count at Indicated Time-points
Period 2; Day -1, 24 Hours Pre-dose;n=13,12
|
4.804 10^12 cells per liter
Standard Deviation 0.403
|
4.918 10^12 cells per liter
Standard Deviation 0.498
|
|
Erythrocyte Count at Indicated Time-points
Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
4.630 10^12 cells per liter
Standard Deviation 0.441
|
4.752 10^12 cells per liter
Standard Deviation 0.454
|
|
Erythrocyte Count at Indicated Time-points
Period 1; Day -1, 24 Hours Pre-dose;n=13,13
|
4.975 10^12 cells per liter
Standard Deviation 0.415
|
4.922 10^12 cells per liter
Standard Deviation 0.442
|
|
Erythrocyte Count at Indicated Time-points
Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
4.812 10^12 cells per liter
Standard Deviation 0.429
|
4.733 10^12 cells per liter
Standard Deviation 0.466
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Findings for Urinalysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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.
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13
|
107.2 Millimeters of mercury
Standard Deviation 9.81
|
109.8 Millimeters of mercury
Standard Deviation 9.25
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 1; Day 1, 2 Hours Post-dose;n=13,13
|
108.4 Millimeters of mercury
Standard Deviation 9.11
|
106.3 Millimeters of mercury
Standard Deviation 9.68
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 1; Day 1, 4 Hours Post-dose;n=13,13
|
109.2 Millimeters of mercury
Standard Deviation 10.49
|
108.8 Millimeters of mercury
Standard Deviation 7.22
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 2; Day 2, 24 Hours Post-dose=13,12
|
109.1 Millimeters of mercury
Standard Deviation 5.91
|
107.5 Millimeters of mercury
Standard Deviation 6.88
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP;Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13
|
60.5 Millimeters of mercury
Standard Deviation 8.75
|
62.6 Millimeters of mercury
Standard Deviation 7.46
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP;Period 1; Day 1, 2 Hours Post-dose;n=13,13
|
60.0 Millimeters of mercury
Standard Deviation 5.76
|
61.2 Millimeters of mercury
Standard Deviation 7.18
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP; Period 1;Day 1, 6 Hours Post-dose;n=13,13
|
56.2 Millimeters of mercury
Standard Deviation 6.38
|
56.5 Millimeters of mercury
Standard Deviation 3.62
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP; Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
59.1 Millimeters of mercury
Standard Deviation 4.92
|
60.5 Millimeters of mercury
Standard Deviation 6.81
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP;Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12
|
60.7 Millimeters of mercury
Standard Deviation 6.14
|
60.0 Millimeters of mercury
Standard Deviation 4.00
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP;Period 2; Day 1, 2 Hours Post-dose;n=13,12
|
60.8 Millimeters of mercury
Standard Deviation 3.87
|
59.7 Millimeters of mercury
Standard Deviation 6.69
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP; Period 2;Day 1, 4 Hours Post-dose;n=13,12
|
57.7 Millimeters of mercury
Standard Deviation 5.63
|
60.9 Millimeters of mercury
Standard Deviation 4.96
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP; Period 2;Day 1, 6 Hours Post-dose;n=13,12
|
55.2 Millimeters of mercury
Standard Deviation 3.39
|
56.5 Millimeters of mercury
Standard Deviation 3.92
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP; Period 2; Day 2, 24 Hours Post-dose;n=13,12
|
64.5 Millimeters of mercury
Standard Deviation 5.98
|
60.8 Millimeters of mercury
Standard Deviation 4.53
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 1; Day 1, 6 Hours Post-dose;n=13,13
|
106.3 Millimeters of mercury
Standard Deviation 9.36
|
104.1 Millimeters of mercury
Standard Deviation 7.76
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 1; Day 2, 24 Hours Post-dose;n=13,13
|
104.6 Millimeters of mercury
Standard Deviation 8.83
|
105.5 Millimeters of mercury
Standard Deviation 6.29
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12
|
104.0 Millimeters of mercury
Standard Deviation 5.83
|
105.8 Millimeters of mercury
Standard Deviation 4.83
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 2; Day 1, 2 Hours Post-dose;n=13,12
|
106.9 Millimeters of mercury
Standard Deviation 5.82
|
104.9 Millimeters of mercury
Standard Deviation 9.67
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 2; Day 1, 4 Hours Post-dose=13,12
|
105.0 Millimeters of mercury
Standard Deviation 7.60
|
108.9 Millimeters of mercury
Standard Deviation 8.02
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
SBP;Period 2; Day 1, 6 Hours Post-dose=13,12
|
103.6 Millimeters of mercury
Standard Deviation 9.18
|
107.8 Millimeters of mercury
Standard Deviation 7.56
|
|
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
DBP; Period 1;Day 1, 4 Hours Post-dose;n=13,13
|
60.2 Millimeters of mercury
Standard Deviation 6.89
|
59.8 Millimeters of mercury
Standard Deviation 5.64
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Respiratory Rate at Indicated Time-points
Period 1; Day 1, 1.5 Hours Pre-dose;n=13,13
|
17.2 Breaths per minute
Standard Deviation 2.35
|
16.6 Breaths per minute
Standard Deviation 1.85
|
|
Respiratory Rate at Indicated Time-points
Period 1;Day 1, 2 Hours Post-dose;n=13,13
|
15.1 Breaths per minute
Standard Deviation 2.53
|
15.2 Breaths per minute
Standard Deviation 2.09
|
|
Respiratory Rate at Indicated Time-points
Period 1;Day 1, 6 Hours Post-dose;n=13,13
|
16.6 Breaths per minute
Standard Deviation 1.26
|
16.2 Breaths per minute
Standard Deviation 2.08
|
|
Respiratory Rate at Indicated Time-points
Period 1;Day 2, 24 Hours Post-dose;n=13,13
|
16.3 Breaths per minute
Standard Deviation 3.15
|
16.6 Breaths per minute
Standard Deviation 2.63
|
|
Respiratory Rate at Indicated Time-points
Period 2; Day 1, 1.5 Hours Pre-dose;n=13,12
|
17.0 Breaths per minute
Standard Deviation 2.16
|
16.7 Breaths per minute
Standard Deviation 1.92
|
|
Respiratory Rate at Indicated Time-points
Period 2;Day 1, 2 Hours Post-dose;n=13,12
|
15.0 Breaths per minute
Standard Deviation 2.45
|
16.3 Breaths per minute
Standard Deviation 3.25
|
|
Respiratory Rate at Indicated Time-points
Period 2;Day 1, 4 Hours Post-dose;n=13,12
|
15.7 Breaths per minute
Standard Deviation 2.69
|
16.8 Breaths per minute
Standard Deviation 1.59
|
|
Respiratory Rate at Indicated Time-points
Period 2;Day 1, 6 Hours Post-dose;n=13,12
|
15.8 Breaths per minute
Standard Deviation 2.51
|
16.2 Breaths per minute
Standard Deviation 2.48
|
|
Respiratory Rate at Indicated Time-points
Period 2;Day 2, 24 Hours Post-dose;n=13,12
|
16.8 Breaths per minute
Standard Deviation 1.92
|
17.2 Breaths per minute
Standard Deviation 2.48
|
|
Respiratory Rate at Indicated Time-points
Period 1;Day 1, 4 Hours Post-dose;n=13,13
|
17.4 Breaths per minute
Standard Deviation 1.89
|
16.5 Breaths per minute
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Pulse Rate at Indicated Time-points
Period 1;Day 1, 2 Hours Post-dose;n=13,13
|
64.2 Beats per minute
Standard Deviation 9.41
|
67.0 Beats per minute
Standard Deviation 12.17
|
|
Pulse Rate at Indicated Time-points
Period 1;Day 1, 4 Hours Post-dose;n=13,13
|
65.5 Beats per minute
Standard Deviation 11.30
|
68.2 Beats per minute
Standard Deviation 12.75
|
|
Pulse Rate at Indicated Time-points
Period 1;Day 1, 6 Hours Post-dose;n=13,13
|
72.5 Beats per minute
Standard Deviation 11.83
|
76.6 Beats per minute
Standard Deviation 13.30
|
|
Pulse Rate at Indicated Time-points
Period 2;Day 2, 24 Hours Post-dose;n=13,12
|
67.2 Beats per minute
Standard Deviation 9.07
|
66.3 Beats per minute
Standard Deviation 10.01
|
|
Pulse Rate at Indicated Time-points
Period 1;Day 1, 1.5 Hours Pre-dose;n=13,13
|
63.2 Beats per minute
Standard Deviation 11.29
|
69.4 Beats per minute
Standard Deviation 12.99
|
|
Pulse Rate at Indicated Time-points
Period 1;Day 2, 24 Hours Post-dose;n=13,13
|
63.5 Beats per minute
Standard Deviation 9.63
|
63.9 Beats per minute
Standard Deviation 10.67
|
|
Pulse Rate at Indicated Time-points
Period 2;Day 1, 1.5 Hours Pre-dose;n=13,12
|
67.4 Beats per minute
Standard Deviation 13.00
|
66.0 Beats per minute
Standard Deviation 10.26
|
|
Pulse Rate at Indicated Time-points
Period 2;Day 1, 2 Hours Post-dose;n=13,12
|
67.0 Beats per minute
Standard Deviation 9.51
|
66.3 Beats per minute
Standard Deviation 11.36
|
|
Pulse Rate at Indicated Time-points
Period 2;Day 1, 4 Hours Post-dose;n=13,12
|
67.8 Beats per minute
Standard Deviation 11.26
|
68.8 Beats per minute
Standard Deviation 10.28
|
|
Pulse Rate at Indicated Time-points
Period 2;Day 1, 6 Hours Post-dose;n=13,12
|
76.8 Beats per minute
Standard Deviation 11.06
|
78.0 Beats per minute
Standard Deviation 12.17
|
SECONDARY outcome
Timeframe: Up to Day 2 of each treatment periodPopulation: Safety Population
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).
Outcome measures
| Measure |
Ciprofloxacin 500 mg Reference
n=26 Participants
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.
|
GR37547 500 mg
n=25 Participants
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.
|
|---|---|---|
|
Body Temperature at Indicated Time-points
Period 2;Day 1, 2 Hours Post-dose;n=13,12
|
36.62 Degree Celsius
Standard Deviation 0.361
|
36.17 Degree Celsius
Standard Deviation 0.334
|
|
Body Temperature at Indicated Time-points
Period 2;Day 1, 4 Hours Post-dose;n=13,12
|
36.75 Degree Celsius
Standard Deviation 0.454
|
36.63 Degree Celsius
Standard Deviation 0.234
|
|
Body Temperature at Indicated Time-points
Period 2;Day 1, 6 Hours Post-dose;n=13,12
|
36.62 Degree Celsius
Standard Deviation 0.392
|
36.75 Degree Celsius
Standard Deviation 0.480
|
|
Body Temperature at Indicated Time-points
Period 2;Day 2, 24 Hours Post-dose;n=13,12
|
36.38 Degree Celsius
Standard Deviation 0.458
|
36.38 Degree Celsius
Standard Deviation 0.414
|
|
Body Temperature at Indicated Time-points
Period 1;Day 1, 1.5 Hours Pre-dose;n=13,13
|
36.43 Degree Celsius
Standard Deviation 0.455
|
36.47 Degree Celsius
Standard Deviation 0.440
|
|
Body Temperature at Indicated Time-points
Period 1;Day 1, 2 Hours Post-dose;n=13,13
|
36.68 Degree Celsius
Standard Deviation 0.393
|
36.62 Degree Celsius
Standard Deviation 0.430
|
|
Body Temperature at Indicated Time-points
Period 1;Day 1, 4 Hours Post-dose;n=13,13
|
36.51 Degree Celsius
Standard Deviation 0.377
|
36.48 Degree Celsius
Standard Deviation 0.443
|
|
Body Temperature at Indicated Time-points
Period 1;Day 1, 6 Hours Post-dose;n=13,13
|
36.55 Degree Celsius
Standard Deviation 0.433
|
36.81 Degree Celsius
Standard Deviation 0.403
|
|
Body Temperature at Indicated Time-points
Period 1;Day 2, 24 Hours Post-dose;n=13,13
|
36.33 Degree Celsius
Standard Deviation 0.312
|
36.38 Degree Celsius
Standard Deviation 0.363
|
|
Body Temperature at Indicated Time-points
Period 2;Day 1, 1.5 Hours Pre-dose;n=13,12
|
36.28 Degree Celsius
Standard Deviation 0.396
|
36.14 Degree Celsius
Standard Deviation 0.300
|
Adverse Events
GR37547 500 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Ciprofloxacin 500 mg Reference
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GR37547 500 mg
n=26 participants at risk
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.
|
Ciprofloxacin 500 mg Reference
n=25 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
4.0%
1/25 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/25 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.8%
1/26 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/25 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
4.0%
1/25 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
8.0%
2/25 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
4.0%
1/25 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/26 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
4.0%
1/25 • Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 4 weeks in each treatment period.
SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER