Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

Trichomoniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591889
• Other study ID #: TINI-T500-PVFD-1
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2012
• Last updated: January 19, 2018
• Start date: September 2009
• Est. completion date: September 2009

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomoniasis

Intervention

Drug:
• Tinidazole
500 mg tablet
• Tinidazole
500 mg tablet

Locations

Country	Name	City	State
United States	Novum Pharmaceutical Research Services	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence determined by statistical comparison Cmax		8 days