Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

NCT01020877 | Completed Phase 1 Results

• 1 other identifier: 10136019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects; Healthy, Normal Subjects

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Metronidazole Vaginal Gel

Drug: Metronidazole

2

ACTIVE COMPARATOR

MetroGel-Vaginal®

Drug: Metronidazole

Interventions

Metronidazole DRUG

Vaginal Gel, 0.75%

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Interventions

Metronidazole; Benchmarking

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: TEVA Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Shirley A Kennedy, MD

  Novum Pharmaceutical Research Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 26, 2009
• Study Start: November 1, 2001
• Primary Completion: November 1, 2001
• Study Completion: January 1, 2002
• Last Updated: June 29, 2010
• Results First Posted: March 23, 2010

Record last verified: 2010-06

Locations

US (1)