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

November 24, 2009
June 21, 2010
November 2001
November 2001   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT01020877 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Metronidazole
    Vaginal Gel, 0.75%
  • Drug: Metronidazole
    Vaginal Gel, 0.75%
    Other Name: MetroGel-Vaginal®
  • Experimental: 1
    Metronidazole Vaginal Gel
    Intervention: Drug: Metronidazole
  • Active Comparator: 2
    MetroGel-Vaginal®
    Intervention: Drug: Metronidazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
January 2002
November 2001   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01020877
10136019
No
Associate Director, Biopharmaceutics, Teva Pharmaceuticals USA
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Shirley A Kennedy, MD Novum Pharmaceutical Research Services
Teva Pharmaceuticals USA
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP