Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
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

May 1, 2012
January 17, 2014
September 2009
September 2009   (final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01591889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Trichomoniasis
  • Drug: Tinidazole
    500 mg tablet
    Other Name: Tindamax®
  • Drug: Tinidazole
    500 mg tablet
    Other Name: Tindamax
  • Active Comparator: tindamax
    500 mg tablet
    Intervention: Drug: Tinidazole
  • Active Comparator: tinidazole
    500 mg tablet
    Intervention: Drug: Tinidazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01591889
TINI-T500-PVFD-1
No
Roxane Laboratories
Roxane Laboratories
Not Provided
Principal Investigator: Soran Hong, MD Novum Pharmaceutical Research Services
Roxane Laboratories
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP