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Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Trichomoniasis

Intervention: Tinidazole (Drug); Tinidazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Roxane Laboratories

Official(s) and/or principal investigator(s):
Soran Hong, MD, Principal Investigator, Affiliation: Novum Pharmaceutical Research Services

Summary

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

Clinical Details

Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

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

Primary outcome: bioequivalence determined by statistical comparison Cmax

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical

history, or clinical laboratory results during screening 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.

Locations and Contacts

Novum Pharmaceutical Research Services, Houston, Texas 77042, United States
Additional Information

Starting date: September 2009
Last updated: January 17, 2014

Page last updated: August 23, 2015

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