Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Metronidazole
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Metronidazole Vaginal Gel | Drug: Metronidazole<br>* Vaginal Gel, 0.75%<br>|
| Active Comparator: 2<br>MetroGel-Vaginal® | Drug: Metronidazole<br>* Vaginal Gel, 0.75%<br>* Other names: MetroGel-Vaginal®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects, Healthy, Normal Subjects