Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
This study has been completed.
Sponsor:
Roxane Laboratories
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
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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: 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 ]
| 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) |
| 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
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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
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 |
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 May 22, 2017