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Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Metronidazole (Drug); Metronidazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Shirley A Kennedy, MD, Principal Investigator, Affiliation: Novum Pharmaceutical Research Services

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.

Clinical Details

Official title: A Study to Evaluate the Relative Bioavailability of Two Metronidazole Vaginal Gel Formulations

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Novum Pharmaceutical Research Services, Pittsburgh, Pennsylvania 15206, United States
Additional Information

Starting date: November 2001
Last updated: June 21, 2010

Page last updated: August 23, 2015

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