Back to resultsCrossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
Primary Purpose
Trichomoniasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tinidazole
Tinidazole
Sponsored by
About this trial
This is an interventional treatment trial for Trichomoniasis
Eligibility 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.
Sites / Locations
- Novum Pharmaceutical Research Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tindamax
tinidazole
Arm Description
500 mg tablet
500 mg tablet
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01591889
Brief Title
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
Official Title
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichomoniasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tindamax
Arm Type
Active Comparator
Arm Description
500 mg tablet
Arm Title
tinidazole
Arm Type
Active Comparator
Arm Description
500 mg tablet
Intervention Type
Drug
Intervention Name(s)
Tinidazole
Other Intervention Name(s)
Tindamax®
Intervention Description
500 mg tablet
Intervention Type
Drug
Intervention Name(s)
Tinidazole
Other Intervention Name(s)
Tindamax
Intervention Description
500 mg tablet
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soran Hong, MD
Organizational Affiliation
Novum Pharmaceutical Research Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novum Pharmaceutical Research Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
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