NCT00649727

Fed Study of Oxybutynin Chloride Extended-release Tablets 10 mg and Ditropan XL® Tablets 10 mg

Single-Dose Food In Vivo Bioequivalence Study of Oxybutynin Chloride Extended-release Tablets (10 mg; Mylan) and Ditropan XL® Tablets(10 mg; ALZA) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 an oral, single 20 mg (2 x 10 mg) dose under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxybutynin Chloride ER Tablets 10 mg	2x10mg, single dose fed
DRUG	Ditropan XL® Tablets 10 mg	2x10mg, single dose fed

Timeline

• Start date: 2002-07-01
• Primary completion: 2002-07-01
• Completion: 2002-08-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States