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Food Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg

NCT00648843 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-04-24

No results posted yet for this study

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 (4 x 5 mg) dose under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Oxybutynin Chloride Extended-release Tablets 5 mg

4x5mg, single dose fed

DRUG

Ditropan XL® Tablets 5 mg

4x5mg, single dose fed

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • James D Carlson, Pharm. D. · PRACS Institute Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2002-12-31
Completion
2003-01-31

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 NCT00648843 on ClinicalTrials.gov