Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01020877|
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : March 23, 2010
Last Update Posted : June 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Metronidazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Relative Bioavailability of Two Metronidazole Vaginal Gel Formulations|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||November 2001|
|Actual Study Completion Date :||January 2002|
Metronidazole Vaginal Gel
Vaginal Gel, 0.75%
Active Comparator: 2
Vaginal Gel, 0.75%
Other Name: MetroGel-Vaginal®
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 60 hour period. ]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. ]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. ]Bioequivalence based on AUC0-inf.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020877
|United States, Pennsylvania|
|Novum Pharmaceutical Research Services|
|Pittsburgh, Pennsylvania, United States, 15206|
|Principal Investigator:||Shirley A Kennedy, MD||Novum Pharmaceutical Research Services|