Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

Completed · Phase 1

Conditions studied: Trichomoniasis

In brief

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

Key facts

Study ID

NCT01591889

Run by

Roxane Laboratories

People needed

28

Starts

2009-09-01

Expected to finish

2009-09-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Novum Pharmaceutical Research Services — Houston, Texas, United States

Full record on ClinicalTrials.gov

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