NCT00649272

Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxybutynin Chloride Extended-Release Tablets, 15 mg	15mg, single dose fasting
DRUG	Ditropan XL® Extended-release tablets, 15 mg	15mg, single dose fasting

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-01-01
• Completion: 2006-02-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States