Trial Outcomes & Findings for Metformin ER 750 mg Tablets, Fasting (NCT NCT00834743)
NCT ID: NCT00834743
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Blood samples collected over a 36 hour period.
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Test (Metformin) First
750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
|
Reference (Glucophage®) First
750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
16
|
|
First Intervention
COMPLETED
|
16
|
16
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout of 7 Days
STARTED
|
16
|
16
|
|
Washout of 7 Days
COMPLETED
|
16
|
16
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
16
|
16
|
|
Second Intervention
COMPLETED
|
15
|
16
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test (Metformin) First
750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
|
Reference (Glucophage®) First
750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
|
|---|---|---|
|
Second Intervention
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Metformin ER 750 mg Tablets, Fasting
Baseline characteristics by cohort
| Measure |
Test (Metformin) First
n=16 Participants
750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
|
Reference (Glucophage®) First
n=16 Participants
750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
|
Total
n=32 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
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 36 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Cmax.
Outcome measures
| Measure |
Test (Metformin)
n=31 Participants
750 mg Metformin Extended Release Tablets test product dosed in either period.
|
Reference (Glucophage®)
n=31 Participants
750 mg Glucophage® XR Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
|
875.86 ng/mL
Standard Deviation 276.2
|
886.39 ng/mL
Standard Deviation 297.74
|
PRIMARY outcome
Timeframe: Blood samples collected over a 36 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-t.
Outcome measures
| Measure |
Test (Metformin)
n=31 Participants
750 mg Metformin Extended Release Tablets test product dosed in either period.
|
Reference (Glucophage®)
n=31 Participants
750 mg Glucophage® XR Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
6068.12 ng*h/mL
Standard Deviation 2052.11
|
6188.74 ng*h/mL
Standard Deviation 2293.91
|
PRIMARY outcome
Timeframe: Blood samples collected over a 36 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on AUC0-inf.
Outcome measures
| Measure |
Test (Metformin)
n=31 Participants
750 mg Metformin Extended Release Tablets test product dosed in either period.
|
Reference (Glucophage®)
n=31 Participants
750 mg Glucophage® XR Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
|
6301.73 pg*h/mL
Standard Deviation 2175.6
|
6495.16 pg*h/mL
Standard Deviation 2442.93
|
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 The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER