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Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg

NCT00649129 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

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 (2 x 10 mg) dose under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Oxybutynin Chloride ER Tablets 10 mg

2x10mg, single dose fasting

DRUG

Ditropan XL® Tablets 10 mg

2x10mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Thomas S Clark, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2002-08-31
Completion
2002-08-31

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 NCT00649129 on ClinicalTrials.gov