Bioequivalency Study of Torsemide Tablets Under Fasting Conditions

This study has been completed.

First Received on January 15, 2008. Last Updated on February 7, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602303

Purpose

The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting 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 Fasting 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: NCT00602303

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:	NCT00602303 History of Changes
Other Study ID Numbers:	TORE-01
Study First Received:	January 15, 2008
Last Updated:	February 7, 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 February 12, 2012