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

NCT00649272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-04-24

No results posted yet for this study

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

DRUG

Oxybutynin Chloride Extended-Release Tablets, 15 mg

15mg, single dose fasting

DRUG

Ditropan XL® Extended-release tablets, 15 mg

15mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Alan K Copa, Pharm. D. · PRACS Institute Ltd. - Cetero Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2006-01-31
Completion
2006-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00649272 on ClinicalTrials.gov