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Bioequivalency Study of Torsemide Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00602615
First received: January 15, 2008
Last updated: February 5, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention
Edema
 Drug: Torsemide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of 20 mg Torsemide Tablets Under Fed Conditions

Resource links provided by NLM:

MedlinePlus related topics: Edema
Drug Information available for: Torsemide
U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: Baseline, Two period, Seven day washout ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 Torsemide or any comparable or similar product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602615

Locations
United States, Missouri
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65801
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Dennis Morrison, DO Bio-Kinetic Clinical Applications, Inc.
  More Information

No publications provided

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00602615     History of Changes
Other Study ID Numbers: TORE-02
Study First Received: January 15, 2008
Last Updated: February 5, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Signs and Symptoms
Torsemide
Diuretics
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013