Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

Phase 1

Completed

• Conditions: Trichomoniasis
• Interventions: Drug: Tinidazole

• Registration Number: NCT01591889
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

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Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to tinidazole or any comparable or similar product.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tindamax	Tinidazole	500 mg tablet
tinidazole	Tinidazole	500 mg tablet

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	8 days

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Houston, Texas, United States