Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
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ClinicalTrials.gov Identifier: NCT01591889 |
Recruitment Status
:
Completed
First Posted
: May 4, 2012
Last Update Posted
: January 23, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Trichomoniasis | Drug: Tinidazole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
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 |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
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
|
- bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, Texas | |
Novum Pharmaceutical Research Services | |
Houston, Texas, United States, 77042 |
Principal Investigator: | Soran Hong, MD | Novum Pharmaceutical Research Services |
Responsible Party: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT01591889 History of Changes |
Other Study ID Numbers: |
TINI-T500-PVFD-1 |
First Posted: | May 4, 2012 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
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 |