Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
Condition: Healthy
Intervention: Metronidazole; Metronidazole
Intervention description: Vaginal Gel, 0.75%; Vaginal Gel, 0.75%
Intervention MeSH terms: Metronidazole
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects; Healthy, Normal Subjects

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.
    

Eligibility 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.