Trial Outcomes & Findings for Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fed (NCT NCT00835991)
NCT ID: NCT00835991
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Blood samples collected over 36 hour period
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Glyburide Metformin (Test) First
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
|
Glucovance® (Reference) First
Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
30
|
30
|
|
First Intervention
COMPLETED
|
30
|
29
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Washout
STARTED
|
30
|
29
|
|
Washout
COMPLETED
|
27
|
26
|
|
Washout
NOT COMPLETED
|
3
|
3
|
|
Second Intervention
STARTED
|
27
|
26
|
|
Second Intervention
COMPLETED
|
27
|
26
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Glyburide Metformin (Test) First
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
|
Glucovance® (Reference) First
Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
|
Washout
Protocol Violation
|
0
|
2
|
|
Washout
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fed
Baseline characteristics by cohort
| Measure |
Glyburide Metformin (Test) First
n=30 Participants
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
|
Glucovance® (Reference) First
n=30 Participants
Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Hispanic
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Glyburide Metformin
n=53 Participants
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
|
Glucovance®
n=53 Participants
Glucovance® 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration) - Glyburide
|
190.17 ng/mL
Standard Deviation 68.08
|
166.48 ng/mL
Standard Deviation 59.87
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Glyburide Metformin
n=53 Participants
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
|
Glucovance®
n=53 Participants
Glucovance® 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide
|
970.22 ng*h/mL
Standard Deviation 328.93
|
977.28 ng*h/mL
Standard Deviation 402.74
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Glyburide Metformin
n=53 Participants
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
|
Glucovance®
n=53 Participants
Glucovance® 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide
|
942.94 ng*h/mL
Standard Deviation 316.17
|
943.45 ng*h/mL
Standard Deviation 388.26
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Glyburide Metformin
n=53 Participants
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
|
Glucovance®
n=53 Participants
Glucovance® 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax (Maximum Observed Concentration) - Metformin
|
755.10 ng/mL
Standard Deviation 195.97
|
766.30 ng/mL
Standard Deviation 210.22
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Glyburide Metformin
n=53 Participants
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
|
Glucovance®
n=53 Participants
Glucovance® 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin
|
6308.12 ng*h/mL
Standard Deviation 1662.69
|
6552.79 ng*h/mL
Standard Deviation 1833.42
|
PRIMARY outcome
Timeframe: Blood samples collected over 36 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Glyburide Metformin
n=53 Participants
Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
|
Glucovance®
n=53 Participants
Glucovance® 5/500 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Metformin
|
6203.57 ng*h/mL
Standard Deviation 1656.57
|
6448.34 ng*h/mL
Standard Deviation 1814.06
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER