Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Roxane Laboratories

ClinicalTrials.gov Identifier:

NCT01591889

First received: May 1, 2012

Last updated: January 17, 2014

Last verified: January 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Trichomoniasis	Drug: Tinidazole	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition

Drug Information available for: Tinidazole

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ] [ Designated as safety issue: No ]


Enrollment:	28
Study Start Date:	September 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: tindamax 500 mg tablet	Drug: Tinidazole 500 mg tablet Other Name: Tindamax®
Active Comparator: tinidazole 500 mg tablet	Drug: Tinidazole 500 mg tablet Other Name: Tindamax

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591889

Locations


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

Sponsors and Collaborators

Roxane Laboratories

Investigators


Principal Investigator:	Soran Hong, MD	Novum Pharmaceutical Research Services

More Information


Responsible Party:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT01591889 History of Changes
Other Study ID Numbers:	TINI-T500-PVFD-1
Study First Received:	May 1, 2012
Last Updated:	January 17, 2014
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Trichomonas Infections Protozoan Infections Parasitic Diseases Tinidazole Alkylating Agents	Molecular Mechanisms of Pharmacological Action Antitrichomonal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 30, 2016

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