NCT00778557

Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fasting Conditions

A Three-Way Crossover, Blinded, Single-Dose, Fasting, Bioequivalence Study of One Test Formulation of Cefprozil 250 mg/5 mL Oral Suspension Versus Two Reference Formulation of Cefzil TM Powder for Oral Suspension (250 mg/5 mL) in Normal Healthy Non-Smoking Male and Female Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study was conducted as a blinded, randomized, 3-way crossover study to compare the single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL) following one 5 mL dose under fasting conditions

Detailed description

The study was designed to compare the rate and extent of absorption of cefprozil from the following products under fasting condition: 1. CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL (Ranbaxy Laboratories Limited, India) 2. Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA) 3. Cefzil TM (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company, New Jersey USA) The bioequivalence of these formulations was assessed for cefprozil. The study will follow a randomized, 3-way cross over, blinded single dose, fasting design in 36 normal healthy, nonsmoking male and female subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL

Timeline

• Start date: 2005-06-01
• Primary completion: 2005-06-01
• Completion: 2005-07-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: Canada