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Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01020877
First received: November 24, 2009
Last updated: June 21, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Metronidazole
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Study to Evaluate the Relative Bioavailability of Two Metronidazole Vaginal Gel Formulations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Cmax.

  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on AUC0-t.

  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 60 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on AUC0-inf.


Enrollment: 38
Study Start Date: November 2001
Study Completion Date: January 2002
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Metronidazole Vaginal Gel
 Drug: Metronidazole
Vaginal Gel, 0.75%
Active Comparator: 2
MetroGel-Vaginal®
 Drug: Metronidazole
Vaginal Gel, 0.75%
Other Name: MetroGel-Vaginal®

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020877

Locations
United States, Pennsylvania
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Shirley A Kennedy, MD Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01020877     History of Changes
Other Study ID Numbers: 10136019
Study First Received: November 24, 2009
Results First Received: February 22, 2010
Last Updated: June 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects
Healthy, Normal Subjects

Additional relevant MeSH terms:
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013