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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650481 |
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 a single, oral 20 mg (4 x 5 mg) dose under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Oxybutynin Chloride Extended-release Tablets 5 mg Drug: Ditropan XL® Tablets 5 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Oxybutynin Chloride Extended-Release Tablets (5 mg; Mylan) and Ditropan XL® Tablets (5 mg; ALZA) in Healthy Volunteers |
Enrollment: | 60 |
Study Start Date: | December 2002 |
Study Completion Date: | January 2003 |
Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Oxybutynin Chloride Extended-release Tablets 5 mg
|
Drug: Oxybutynin Chloride Extended-release Tablets 5 mg
4x5mg, single dose fasting
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2: Active Comparator
Ditropan XL® Tablets 5 mg
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Drug: Ditropan XL® Tablets 5 mg
4x5mg, single dose fasting
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | OXYB-02116 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650481 |
Health Authority: | United States: Institutional Review Board |
Oxybutynin Healthy Mandelic Acids |
Parasympatholytics Anti-Infective Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Infective Agents, Urinary |
Renal Agents Cholinergic Agents Pharmacologic Actions Muscarinic Antagonists Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents |