drugset / Trial / NCT00649272

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

NCT00649272

Phase 1 Completed 80 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2006-01
Primary completion
2006-01
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxybutynin Small molecule 15 mg Oral

Indications

No indication recorded.