NCT00650351

Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg

Single-Dose Food In Vivo Bioequivalence Study of Ciprofloxacin Extended-Release Tablets (1000 mg; Mylan) and Cipro® XR Tablets (1000 mg; Bayer) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ciprofloxacin Extended-Release Tablets 1000 mg	1000mg, single dose fed
DRUG	Cipro® XR Tablets 1000 mg	1000mg, single dose fed

Timeline

• Start date: 2005-10-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States