Single-Dose Fasting Bioequivalence Study of Oxybutynin Chloride Extended-Release Tablets (15 mg; Mylan)and Ditropan XL® Tablets (15 mg; ALZA) in Healthy Volunteers

NCT00649272 Phase 1 COMPLETED

The objective of this study was to investigate the bioequivalence of Oxybutynin Chloride Extended-Release Tablets, 15 mg (Mylan Pharmaceuticals Inc.) to Ditropan XL® Extended- Release Tablets, 15 mg (ALZA Corporation; Distributed and marketed by: Ortho-McNeil Pharmaceuticals Inc.) following a single, oral 15 mg dose (1 x 15 mg tablet) under fasting conditions.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	80
Start date	2006-01
Completion	2006-02

Conditions

• Healthy

Interventions

• Oxybutynin Chloride Extended-Release Tablets, 15 mg
• Ditropan XL® Extended-release tablets, 15 mg

Primary outcomes

• Bioequivalence — within 30 days

Countries

United States