Phase 1
Completed N=28
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Source: ClinicalTrials.gov NCT01068730 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) — 7062.76; 7187.14; 11577.85; 11424.73 ng*hr/mL
Summary
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) |
7062.76; 7187.14; 11577.85; 11424.73 | — |
| PRIMARY Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax) |
1013.57; 1019.59; 1635.30; 1593.20 | — |
| SECONDARY Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs) |
6; 2; 5; 6; 0; 0 | — |
| SECONDARY Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE |
0; 0; 0; 0 | — |
| SECONDARY Participants With Abnormal Physical Findings |
0; 0; 0; 0 | — |
| SECONDARY Participants With Abnormal Vital Sign Findings Reported as an AE |
0; 0; 0; 0 | — |
| SECONDARY Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology |
0; 0; 0; 0 | — |
| SECONDARY Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry |
0; 0; 0; 0 | — |
| SECONDARY Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women ages 18 to 55 inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²
Exclusion Criteria
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- History of allergy or intolerance to metformin or other similar acting agents
- Prior exposure to metformin within 3 months of study drug administration
- Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula
Data sourced from ClinicalTrials.gov (NCT01068730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.