Bioequivalency Study of Torsemide Tablets Under Fed Conditions

Edema Clinical Trial

Official title:

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of 20 mg Torsemide Tablets Under Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602615
• Other study ID #: TORE-02
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: January 19, 2018
• Start date: September 2003
• Est. completion date: September 2003

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edema

Intervention

Drug:
• Torsemide

Locations

Country	Name	City	State
United States	Bio-Kinetic Clinical Applications, Inc.	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two period, Seven day washout