NCT00778180

Bioequivalence Study of Furosemide 80mg Tablets Under Fasting Conditions

A Study to Compare the Relative Bioavailability of Ranbaxy and Aventis Formulations of Furosemide 80 mg Tablets in Healthy Adult Volunteers Under Fasted Condition.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the relative bioavailability of the test formulation of furosemide 80 mg tablets (Ohm Laboratories, Inc.) with an already marketed reference formulation Lasix® (furosemide) 80 mg tablets (Aventis Pharmaceuticals NJ) under fasted conditions in healthy adult human subjects

Detailed description

This randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 80 mg furosemide tablets under fasted conditions. The study was conducted with 44 (39 completing) healthy adults in accordance with protocol. In each study period, a single 80 mg dose was administered to the subjects following an overnight fast. The test formulation was furosemide 80 mg tablet (Ohm Laboratories, Inc.), and the reference formulation was Lasix® (furosemide) 80 mg tablet (Aventis Pharmaceuticals NJ). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments. Blood samples were collected pre-dose and at intervals over 12 hours after each dose. The plasma samples for all subjects completing both periods of the study were sent to BA Research, 10550 Rockley Road, Suite 150, Houston, Texas 77099, Telephone: [phone], Fax [phone] for determination of furosemide plasma concentration. Statistical analysis was performed at Ba Research, 2591 Sam Bass Road, Round Rock, TX 78681, Telephone [phone], Fax [phone]. A total of 44 subjects were randomized to receive single oral dose of 80 mg furosemide tablets and 39 subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	furosemide 80 mg tablets

Timeline

• Start date: 2005-10-01
• Primary completion: 2005-10-01
• Completion: 2005-11-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States