Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects Healthy, Normal Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 38
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Metronidazole Vaginal Gel arm 2: MetroGel-Vaginal®

Interventions: intervention 1: Metronidazole intervention 2: Metronidazole
Intervention descriptions: intervention 1: Vaginal Gel, 0.75% intervention 2: Vaginal Gel, 0.75%

Protocol document: