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

NCT00650481 Phase 1 COMPLETED

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.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	60
Start date	2002-12
Completion	2003-01

Conditions

• Healthy

Interventions

• Oxybutynin Chloride Extended-release Tablets 5 mg
• Ditropan XL® Tablets 5 mg

Primary outcomes

• Bioequivalence — within 30 days

Countries

United States