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Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591889
First Posted: May 4, 2012
Last Update Posted: January 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roxane Laboratories
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 1, 2012
First Posted: May 4, 2012
Last Update Posted: January 20, 2014
Last Verified: January 2014

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