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Bioequivalency Study of Torsemide Tablets Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00602615
First Posted: January 28, 2008
Last Update Posted: February 8, 2008
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:
Roxane Laboratories
January 15, 2008
January 28, 2008
February 8, 2008
September 2003
September 2003   (Final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ]
Same as current
Complete list of historical versions of study NCT00602615 on ClinicalTrials.gov Archive Site
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Bioequivalency Study of Torsemide Tablets Under Fed Conditions
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of 20 mg Torsemide Tablets Under Fed Conditions
The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.
Not Provided
Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Edema
Drug: Torsemide
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2003
September 2003   (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 Torsemide 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
 
 
NCT00602615
TORE-02
No
Not Provided
Not Provided
Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: Dennis Morrison, DO Bio-Kinetic Clinical Applications, Inc.
Roxane Laboratories
February 2008

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