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Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591889
First Posted: May 4, 2012
Last Update Posted: January 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roxane Laboratories
May 1, 2012
May 4, 2012
January 20, 2014
September 2009
September 2009   (Final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]
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
Intervention Model: Crossover Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01591889
TINI-T500-PVFD-1
No
Not Provided
Not Provided
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