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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778180 |
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
Condition | Intervention |
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Healthy |
Drug: furosemide 80 mg tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Study to Compare the Relative Bioavailability of Ranbaxy and Aventis Formulations of Furosemide 80 mg Tablets in Healthy Adult Volunteers Under Fasted Condition. |
Enrollment: | 44 |
Study Start Date: | October 2005 |
Study Completion Date: | November 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
furosemide 80 mg tablets of Ranbaxy
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Drug: furosemide 80 mg tablets |
2: Active Comparator
Lasix® (furosemide) 80 mg tablets
|
Drug: furosemide 80 mg tablets |
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: 281-495-6996, Fax 281-575-6996 for determination of furosemide plasma concentration.
Statistical analysis was performed at Ba Research, 2591 Sam Bass Road, Round Rock, TX 78681, Telephone 512-388-4554, Fax 512-388-4550.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
• Males and females aged 18 years of age or older with a body mass index (BMI) in the range 18-30 kg/m2 inclusive, measured according to Novum Standard Operating Procedures.
Exclusion Criteria:
Females who are pregnant, lactating or likely to become pregnant during the study.
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | 10540344 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778180 |
Health Authority: | United States: Institutional Review Board |
Bioequivalence furosemide 80 mg tablets |
Healthy Furosemide |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Diuretics Cardiovascular Agents Sodium Potassium Chloride Symporter Inhibitors Pharmacologic Actions |