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Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

NCT01020877 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2010-06-29

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Metronidazole

Vaginal Gel, 0.75%

DRUG

Metronidazole

Vaginal Gel, 0.75%

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Shirley A Kennedy, MD · Novum Pharmaceutical Research Services

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2001-11-30
Completion
2002-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01020877 on ClinicalTrials.gov