NCT00650481

Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Oxybutynin Chloride Extended-release Tablets (5 mg; Mylan) and Ditropan XL® Tablets (5 mg; ALZA) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride Extended-release tablets to ALZA's Ditropan XL® tablets following a single, oral 20 mg (4 x 5 mg) dose under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxybutynin Chloride Extended-release Tablets 5 mg	4x5mg, single dose fasting
DRUG	Ditropan XL® Tablets 5 mg	4x5mg, single dose fasting

Timeline

• Start date: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2003-01-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States