Bioequivalency Study of Torsemide Tablets Under Fed Conditions

• Sponsor: Roxane Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00602615
• Collaborator: (none)
• Enrollment: 28
• Location: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Edema	Drug: Torsemide	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Sep 1, 2003
• Actual Study Completion Date: Sep 1, 2003

Outcome Measures

Primary Outcome Measures

1. Bioequivalence [Baseline, Two period, Seven day washout]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00602615
• Other Study ID Numbers: TORE-02
• First Posted: Jan 28, 2008
• Last Update Posted: Jan 23, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Malnutrition; Torsemide

Study Results

No Results Posted as of Jan 23, 2018