Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01591889
Collaborator
(none)
28
1
2
Study Details
Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
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
:
Sep 1, 2009
Actual Primary Completion Date
:
Sep 1, 2009
Actual Study Completion Date
:
Sep 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: tindamax 500 mg tablet |
Drug: Tinidazole
500 mg tablet
Other Names:
|
| Active Comparator: tinidazole 500 mg tablet |
Drug: Tinidazole
500 mg tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- bioequivalence determined by statistical comparison Cmax [8 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novum Pharmaceutical Research Services | Houston | Texas | United States | 77042 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
- Principal Investigator: Soran Hong, MD, Novum Pharmaceutical Research Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01591889
Other Study ID Numbers:
- TINI-T500-PVFD-1
First Posted:
May 4, 2012
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018