Trial Outcomes & Findings for Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects (NCT NCT01068730)
NCT ID: NCT01068730
Last Updated: 2015-05-08
Results Overview
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing
Results posted on
2015-05-08
Participant Flow
A total of 28 participants who met all of the inclusion and none of the exclusion criteria were planned and enrolled in the study from a single site in the United States.
Participants were screened for eligibility within 21 days before Day 1 of period 1. On Day -1 of each period, the participants were admitted to the clinical facility and confined for 4 days. All the 28 participants were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). The washout between each dose was at least 7 days.
Participant milestones
| Measure |
Treatment Sequence ADBC
Treatment A (period 1): single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment D (period 2): single oral 1000-mg Glucophage (metformin) tablet administered under fed condition. Treatment B (period 3): single oral 500-mg Glucophage tablet administered under fed condition. Treatment C (period 4): single oral 1000-mg Diabex tablet administered under fed condition.
|
Treatment Sequence BACD
Treatment B (period 1): single oral 500-mg Glucophage tablet administered under fed condition. Treatment A (period 2): single oral 500-mg Diabex tablet administered under fed condition. Treatment C (period 3): single oral 1000-mg Diabex tablet administered under fed condition. Treatment D (period 4): single oral 1000-mg Glucophage tablet administered under fed condition.
|
Treatment Sequence CBDA
Treatment C (period 1): single oral 1000-mg Diabex tablet administered under fed condition. Treatment B (period 2): single oral 500-mg Glucophage tablet administered under fed condition. Treatment D (period 3): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment A (period 4): single oral 500-mg Diabex tablet administered under fed condition.
|
Treatment Sequence DCAB
Treatment D (period 1): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment C (period 2): single oral 1000-mg Diabex tablet administered under fed condition. Treatment A (period 3): single oral 500-mg Diabex tablet administered under fed condition. Treatment B (period 4): single oral 500-mg Glucophage tablet administered under fed condition.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
7
|
7
|
|
Period 1
COMPLETED
|
7
|
7
|
7
|
7
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
7
|
7
|
7
|
7
|
|
Period 2
COMPLETED
|
7
|
7
|
7
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
7
|
7
|
7
|
7
|
|
Period 3
COMPLETED
|
6
|
7
|
7
|
7
|
|
Period 3
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 4
STARTED
|
6
|
7
|
7
|
7
|
|
Period 4
COMPLETED
|
6
|
6
|
7
|
7
|
|
Period 4
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence ADBC
Treatment A (period 1): single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment D (period 2): single oral 1000-mg Glucophage (metformin) tablet administered under fed condition. Treatment B (period 3): single oral 500-mg Glucophage tablet administered under fed condition. Treatment C (period 4): single oral 1000-mg Diabex tablet administered under fed condition.
|
Treatment Sequence BACD
Treatment B (period 1): single oral 500-mg Glucophage tablet administered under fed condition. Treatment A (period 2): single oral 500-mg Diabex tablet administered under fed condition. Treatment C (period 3): single oral 1000-mg Diabex tablet administered under fed condition. Treatment D (period 4): single oral 1000-mg Glucophage tablet administered under fed condition.
|
Treatment Sequence CBDA
Treatment C (period 1): single oral 1000-mg Diabex tablet administered under fed condition. Treatment B (period 2): single oral 500-mg Glucophage tablet administered under fed condition. Treatment D (period 3): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment A (period 4): single oral 500-mg Diabex tablet administered under fed condition.
|
Treatment Sequence DCAB
Treatment D (period 1): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment C (period 2): single oral 1000-mg Diabex tablet administered under fed condition. Treatment A (period 3): single oral 500-mg Diabex tablet administered under fed condition. Treatment B (period 4): single oral 500-mg Glucophage tablet administered under fed condition.
|
|---|---|---|---|---|
|
Period 3
Personal reason
|
1
|
0
|
0
|
0
|
|
Period 4
Family emergency
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Enrolled and Treated Participants
n=28 Participants
Participants who were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). Treatment A: single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment B: single oral 500-mg Glucophage tablet administered under fed condition. Treatment C: single oral 1000-mg Diabex tablet administered under fed condition.Treatment D: single oral 1000-mg Glucophage (metformin) tablet administered under fed condition.
|
|---|---|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Height
|
169.54 Centimeter
STANDARD_DEVIATION 11.44 • n=5 Participants
|
|
Weight
|
77.02 kg
STANDARD_DEVIATION 15.88 • n=5 Participants
|
|
Body Mass Index
|
26.58 kg/m^2
STANDARD_DEVIATION 3.64 • n=5 Participants
|
PRIMARY outcome
Timeframe: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosingPopulation: All treated participants with evaluable PK analyses. In treatment D, AUC (0-inf) was not analysed for 1 participant who did not have a clear terminal elimination phase.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=25 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
|
7062.76 ng*hr/mL
Geometric Coefficient of Variation 26.91
|
7187.14 ng*hr/mL
Geometric Coefficient of Variation 25.95
|
11577.85 ng*hr/mL
Geometric Coefficient of Variation 27.36
|
11424.73 ng*hr/mL
Geometric Coefficient of Variation 29.06
|
PRIMARY outcome
Timeframe: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosingPopulation: All treated participants with evaluable PK analyses.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=26 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)
|
1013.57 ng/mL
Geometric Coefficient of Variation 25.67
|
1019.59 ng/mL
Geometric Coefficient of Variation 25.26
|
1635.30 ng/mL
Geometric Coefficient of Variation 27.67
|
1593.20 ng/mL
Geometric Coefficient of Variation 26.87
|
SECONDARY outcome
Timeframe: AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).Population: All treated participants not discontinuing prior to the end of the study.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=27 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
Participants With atleast 1 Treatment-emergent AE
|
6 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
|
Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
Discontinuations Due to AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).Population: All treated participants not discontinuing prior to the end of the study.
Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=27 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
0 Participants
0
|
SECONDARY outcome
Timeframe: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).Population: All treated participants not discontinuing prior to the end of the study.
Physical findings that were considered abnormal by the investigator.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=27 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Participants With Abnormal Physical Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).Population: All treated participants not discontinuing prior to the end of the study.
per investigator
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=27 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Participants With Abnormal Vital Sign Findings Reported as an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).Population: All treated participants not discontinuing prior to the end of the study.
Clinically significant was determined by the investigator.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=27 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).Population: All treated participants not discontinuing prior to the end of the study.
Clinically significant was determined by the investigator.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=27 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).Population: All treated participants not discontinuing prior to the end of the study.
Clinically significant was determined by the investigator.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=27 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosingPopulation: All treated participants with evaluable PK analyses.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=26 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Metformin Pharmacokinetic (PK) Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)
|
3.25 hr
Standard Deviation 0.79
|
3.56 hr
Standard Deviation 0.80
|
3.22 hr
Standard Deviation 0.64
|
3.23 hr
Standard Deviation 0.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosingPopulation: All treated participants with evaluable PK analyses. In treatment D, T 1/2 was not analysed for 1 participant who did not have a clear terminal elimination phase.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=25 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Metformin Pharmacokinetic (PK) Parameter Terminal Half-life (T 1/2)
|
13.2310 hr
Standard Deviation 5.3180
|
11.5349 hr
Standard Deviation 3.7633
|
12.6152 hr
Standard Deviation 4.2032
|
12.5268 hr
Standard Deviation 4.3137
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosingPopulation: All treated participants with evaluable PK analyses.
PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC\[0-t\] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.
Outcome measures
| Measure |
Treatment A - 500 mg Diabex
n=28 Participants
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 Participants
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
Treatment C - 1000 mg Diabex
n=27 Participants
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=26 Participants
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])
|
6907.06 ng*hr/mL
Geometric Coefficient of Variation 27.16
|
7078.70 ng*hr/mL
Geometric Coefficient of Variation 26.18
|
11305.27 ng*hr/mL
Geometric Coefficient of Variation 27.77
|
11129.89 ng*hr/mL
Geometric Coefficient of Variation 28.93
|
Adverse Events
Treatment C - 1000 mg Diabex
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment D - 1000 mg Glucophage
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment A - 500 mg Diabex
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment B - 500 mg Glucophage
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment C - 1000 mg Diabex
n=27 participants at risk
1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
|
Treatment D - 1000 mg Glucophage
n=27 participants at risk
1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
|
Treatment A - 500 mg Diabex
n=28 participants at risk
500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
|
Treatment B - 500 mg Glucophage
n=27 participants at risk
500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
|
|---|---|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.6%
1/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Nervous system disorders
Headache
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.6%
1/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
7.4%
2/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.6%
1/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.6%
1/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
7.4%
2/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
7.1%
2/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
7.4%
2/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
14.8%
4/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
7.1%
2/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
|
General disorders
Feeling of body temperature change
|
3.7%
1/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/28 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
0.00%
0/27 • From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER