Trial Outcomes & Findings for Metformin ER 750 mg Tablets, Fed (NCT NCT00834613)
NCT ID: NCT00834613
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
|
15
|
16
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Washout of 7 Days
STARTED
|
15
|
16
|
|
Washout of 7 Days
COMPLETED
|
15
|
16
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
15
|
16
|
|
Second Intervention
COMPLETED
|
15
|
16
|
|
Second Intervention
NOT COMPLETED
|
0
|
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.
|
|---|---|---|
|
First Intervention
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Metformin ER 750 mg Tablets, Fed
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
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 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)
|
853.63 ng/mL
Standard Deviation 112.2
|
824.89 ng/mL
Standard Deviation 112.58
|
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)
|
8965.41 ng*h/mL
Standard Deviation 1417.83
|
9193.38 ng*h/mL
Standard Deviation 1611.87
|
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)
|
9162.85 ng*h/mL
Standard Deviation 1415.9
|
9397.52 ng*h/mL
Standard Deviation 1620.32
|
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