NCT00778739

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

A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Cefprozil 250 mg/5 mL Oral Suspension Versus 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: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study was conducted as an open-label, randomized, 2-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 fed conditions

Detailed description

The study was designed to compare the rate and extent of absorption of cefprozil from the following products under fed condition: 1. CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL (Ranbaxy Laboratories Limited, India) 2. Cefzil ® (CEFPROZIL) for oral suspension equivalent to 250mg/5mL anhydrous, cefprozil (Bristol-Myers Squibb Company USA) The bioequivalence of these formulations was assessed for cefprozil (Bristol-Myers Squibb Company, USA) Thirty -two subjects (32) were recruited for the study of which 16 were males and 16 were females. All of them completed the study

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