Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Metronidazole

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206
      • Novum Pharmaceutical Research Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females, 18 years of age or older.
• Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
• Signed informed consent form, which meets all criteria of current FDA regulations.
• If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, oral or implanted hormonal contraceptives).
• Weight within + 25% from normal for height and weight for body frame as described in Novum Standard Operating Procedures adapted from the "MetLife® Height and Weight Tablets", Copyright© 1993.

Exclusion Criteria:

• Females who are pregnant, lactating, or likely to become pregnant during the study.
• History of allergy or sensitivity to metronidazole, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
• Significant history or current evidence of chronic infectious disease, system disorder or organ disorder.
• History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
• Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives or hormonal replacement therapy).
• Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
• Receipt of any drug as part of a research study within 30 days prior to dosing.
• Drug or alcohol addiction requiring treatment in the past 12 months.
• Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing.
• Positive test for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
• Positive test results for drugs of abuse at screening.
• Evidence of vulvovaginitis or cervicitis (e.g. Bacterial vaginosis, vaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea, or history of Herpes simplex or human papillomavirus).
• Vulvar or vaginal conditions that may affect absorption of the drug.
• Clinically significant abnormal findings on PAP smear within previous 12 months.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Metronidazole Vaginal Gel	Drug: Metronidazole; Vaginal Gel, 0.75%; Other Names: MetroGel-Vaginal®
Active Comparator: 2; MetroGel-Vaginal®	Drug: Metronidazole; Vaginal Gel, 0.75%; Other Names: MetroGel-Vaginal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)	Bioequivalence based on Cmax.	Blood samples collected over a 60 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	Bioequivalence based on AUC0-t.	Blood samples collected over a 60 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)	Bioequivalence based on AUC0-inf.	Blood samples collected over a 60 hour period.

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Shirley A Kennedy, MD, Novum Pharmaceutical Research Services

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): November 1, 2001
• Study Completion (Actual): January 1, 2002

Study Registration Dates

• First Submitted: November 24, 2009
• First Submitted That Met QC Criteria: November 25, 2009
• First Posted (Estimate): November 26, 2009

Study Record Updates

• Last Update Posted (Estimate): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 21, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects; Healthy, Normal Subjects
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: 10136019