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A Study to Evaluate the Relative Bioavailability of Two Metronidazole Vaginal Gel Formulations
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female subjects.
Details
| Lead sponsor | Teva Pharmaceuticals USA |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 38 |
| Start date | 2001-11 |
| Completion | 2002-01 |
Conditions
- Healthy
Interventions
- Metronidazole
- Metronidazole
Primary outcomes
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma) — Blood samples collected over a 60 hour period.
Bioequivalence based on Cmax. - AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) — Blood samples collected over a 60 hour period.
Bioequivalence based on AUC0-t. - AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) — Blood samples collected over a 60 hour period.
Bioequivalence based on AUC0-inf.
Countries
United States