Last reviewed · How we verify
Bioequivalence of Two Strengths (1000 mg and 500 mg) of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects in an Open, Randomised, Single-dose, Two-period Crossover, Phase I Trial
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
Details
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 56 |
| Start date | 2009-02 |
Conditions
- Healthy
Interventions
- Merck Glucophage® high dose
- BMS Glucophage® high dose
- Merck Glucophage® low dose
- BMS Glucophage® low dose
Primary outcomes
- AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity) — up to 48 h after drug administration
- Cmax (maximum measured concentration of metformin in plasma) — up to 48 hours after drug administration