Trial Outcomes & Findings for BE Study of Metformin GSK 500mg (NCT NCT01710527)
NCT ID: NCT01710527
Last Updated: 2017-06-02
Results Overview
Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.
Results posted on
2017-06-02
Participant Flow
The study was conducted on 32 adult healthy male participants, aged between 18 and 45 years, at a single site of India from 9 May 2012 to 18 May 2012. During each study period participants received test (treatment T-Metformin tablet) and reference (treatment R-Glucophage® tablet) products.
A total of 32 participants were randomized in the period I to receive test (treatment T-Metformin 500 milligram \[mg\] tablet) or reference (treatment R-Glucophage 500 mg tablet).
Participant milestones
| Measure |
Treatment T-Metformin 500mg, Then Treatment R-Glucophage 500mg
Participants received one tablet of treatment T (Metformin 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 minutes (min) for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment R (Glucophage 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 ante meridiem (am) and 8:30 am on Day 1 (dosing day) of each study period.
|
Treatment R-Glucophage 500mg, Then Treatment T-Metformin 500mg
Participants received one tablet of treatment R (Glucophage 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment T (Metformin 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period.
|
|---|---|---|
|
Period 1: Intervention Period 1
STARTED
|
16
|
16
|
|
Period 1: Intervention Period 1
COMPLETED
|
16
|
16
|
|
Period 1: Intervention Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2: Washout Period (7 Days)
STARTED
|
16
|
16
|
|
Period 2: Washout Period (7 Days)
COMPLETED
|
16
|
15
|
|
Period 2: Washout Period (7 Days)
NOT COMPLETED
|
0
|
1
|
|
Period 3: Intervention Period 2
STARTED
|
16
|
15
|
|
Period 3: Intervention Period 2
COMPLETED
|
16
|
15
|
|
Period 3: Intervention Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment T-Metformin 500mg, Then Treatment R-Glucophage 500mg
Participants received one tablet of treatment T (Metformin 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 minutes (min) for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment R (Glucophage 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 ante meridiem (am) and 8:30 am on Day 1 (dosing day) of each study period.
|
Treatment R-Glucophage 500mg, Then Treatment T-Metformin 500mg
Participants received one tablet of treatment R (Glucophage 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment T (Metformin 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period.
|
|---|---|---|
|
Period 2: Washout Period (7 Days)
Personal reasons
|
0
|
1
|
Baseline Characteristics
BE Study of Metformin GSK 500mg
Baseline characteristics by cohort
| Measure |
Treatment T-Metformin 500 mg + Treatment R-Glucophage 500 mg
n=32 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet) or treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|
|
Age, Continuous
|
26.19 Years
STANDARD_DEVIATION 4.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.Population: PK population was defined as all participants who had a PK measurement available. Data is presented for the participants available at the time of assessment.
Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose
|
962.728 Nanogram per milliltre (ng/mL)
Standard Deviation 246.0751
|
985.257 Nanogram per milliltre (ng/mL)
Standard Deviation 223.1331
|
PRIMARY outcome
Timeframe: Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.Population: PK population. Data is presented for the participants available at the time of assessment.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal rule from measured data points from time of administration until the time of last quantifiable concentration. AUC0- infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant. The AUC0- infinity was the sum of the estimated and extrapolated parts.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)
AUC0-t
|
7396.329 ng*hour/mL
Standard Deviation 1869.1737
|
7215.743 ng*hour/mL
Standard Deviation 1865.2930
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)
AUC0-infinity
|
7577.176 ng*hour/mL
Standard Deviation 1856.9193
|
7400.540 ng*hour/mL
Standard Deviation 1866.7596
|
PRIMARY outcome
Timeframe: Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.Population: PK population. Data is presented for the participants available at the time of assessment.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Time of the Maximum Plasma Concentration (T-max) Over Period
|
3.00 hour
Standard Deviation 0.910
|
3.00 hour
Standard Deviation 0.991
|
PRIMARY outcome
Timeframe: Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.Population: PK population. Data is presented for the participants available at the time of assessment.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with elimination rate constant obtained as semi logarithmic plot of the plasma concentration versus time.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Terminal Half-life (T-half) Over Period
|
3.84 hour
Standard Deviation 0.511
|
3.86 hour
Standard Deviation 0.549
|
PRIMARY outcome
Timeframe: Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.Population: PK population. Data is presented for the participants available at the time of assessment.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC%\_Extrapolated was obtained by subtracting AUC0-t from AUC0-infinity divided by AUC0-infinity and multiplied by 100.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUC%_Extrapolated)
|
2.604 Percentage of area
Standard Deviation 1.5408
|
2.684 Percentage of area
Standard Deviation 1.6589
|
PRIMARY outcome
Timeframe: Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.Population: PK population. Data is presented for the participants available at the time of assessment.
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semi logarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=31 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Apparent First-order Elimination or Terminal Rate Constant
|
0.183 1/hour
Standard Deviation 0.0250
|
0.184 1/hour
Standard Deviation 0.0285
|
SECONDARY outcome
Timeframe: Up to 38 daysPopulation: Safety population was defined as participants who received at least one dose of the study drug.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An 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, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalized ratio \>1.5.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=32 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=32 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any AE
|
2 Participants
|
1 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Any SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 38 daysPopulation: Safety population.
Vital signs measurements (blood pressure, respiratory rate, pulse rate and oral temperature) were conducted during screening and during post study safety assessments. Vital signs measurement were also performed at each check-in and at checkout and were also recorded before dosing of study drug, between 2-3, 9-10 and 36.0 hour post-dose. Measurements were recorded in sitting position after rest of at least 5 min.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=32 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=32 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Sign Results
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 38 daysPopulation: Safety population.
Brief physical examination was performed at each check-in, check-out and complete physical examination during screening and at the end of the clinical part of the study.
Outcome measures
| Measure |
Treatment T-Metformin 500 mg
n=32 Participants
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=32 Participants
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Number of Participants With Abnormal Periodic Physical Examination Results
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 38 daysPopulation: Safety population.
Subject well-being questionnaire was planned to be conducted at 1.0 and 5.0 hour post-dose. During vital sign recording each participants was planned to be asked about his well-being recorded during post study safety assessments. The data for this outcome measure was not collected during the study. Thus the results summary for this outcome measure was not produced.
Outcome measures
Outcome data not reported
Adverse Events
Treatment T-Metformin 500 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment R- Glucophage 500 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment T-Metformin 500 mg
n=32 participants at risk
In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
Treatment R- Glucophage 500 mg
n=32 participants at risk
In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • AE's and SAE's were collected up to 38 days.
Safety population was used.
|
0.00%
0/32 • AE's and SAE's were collected up to 38 days.
Safety population was used.
|
|
General disorders
Headache
|
3.1%
1/32 • AE's and SAE's were collected up to 38 days.
Safety population was used.
|
0.00%
0/32 • AE's and SAE's were collected up to 38 days.
Safety population was used.
|
|
General disorders
Tiredness
|
0.00%
0/32 • AE's and SAE's were collected up to 38 days.
Safety population was used.
|
3.1%
1/32 • AE's and SAE's were collected up to 38 days.
Safety population was used.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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