NCT01020877

Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

A Study to Evaluate the Relative Bioavailability of Two Metronidazole Vaginal Gel Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metronidazole	Vaginal Gel, 0.75%
DRUG	Metronidazole	Vaginal Gel, 0.75%

Timeline

• Start date: 2001-11-01
• Primary completion: 2001-11-01
• Completion: 2002-01-01
• First posted: 2009-11-26
• Last updated: 2010-06-29
• Results posted: 2010-03-23

Locations

1 site across 1 country: United States