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Fasting Study of Oxybutynin Chloride Extended-Release Tablets 5 mg and Ditropan XL® Tablets 5 mg
This study has been completed.
First Received: March 30, 2008   Last Updated: March 31, 2008   History of Changes
Sponsored by: Mylan Pharmaceuticals
Information provided by: Mylan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00650481
  Purpose

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

Drug Information available for: Chlorides Oxybutynin chloride Oxybutynin
U.S. FDA Resources
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

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

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
2: Active Comparator
Ditropan XL® Tablets 5 mg
Drug: Ditropan XL® Tablets 5 mg
4x5mg, single dose fasting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 18 years and older.
  2. Sex: Male and/or non-pregnant, non-lactating female

    1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study.
    2. 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:

      1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
      2. barrier methods containing or used in conjunction with a spermicidal agent, or
      3. postmenopausal accompanied with a documented postmenopausal course of at least one year or surgical sterility (tubal ligation, oophorectomy or hysterectomy).
    3. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.
  3. Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
  4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

  1. Institutionalized subjects will not be used.
  2. Social Habits:

    1. Use of any tobacco products within 1 year of the start of the study.
    2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
    3. Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
    4. Any recent, significant change in dietary or exercise habits.
    5. A positive test for any drug included in the urine drug screen.
  3. Medications:

    1. Use of any medication within the 14 days prior to the initial dose of study medication.
    2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
    3. Use of hormonal contraceptives and hormonal replacement therapy within three months prior to the initial dose of study medication.
  4. Diseases:

    1. History of any significant chronic disease.
    2. History of drug and/or alcohol abuse.
    3. Acute illness at the time of either the pre-study medical evaluation or dosing.
    4. A positive HIV, hepatitis B, or hepatitis C test.
    5. Risk or history of urinary retention, gastric retention or narrow angle glaucoma.
  5. Abnormal and clinically significant laboratory test results:

    1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
    2. Abnormal and clinically relevant ECG tracing.
  6. Donation or loss of a significant volume of blood or plasma (> 450 ml) within 28 days prior to the initial dose of study medication.
  7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
  8. Allergy or hypersensitivity to oxybutynin chloride or any other anticholinergics.
  9. History of difficulty in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  10. Consumption of grapefruit or grapefruit-containing products within 7 days of study drug administration.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650481

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: James D Carlson, Pharm. D. PRACS Institute Ltd.
  More Information

Additional Information:
No publications provided

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     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Muscarinic Antagonists
Oxybutynin
Neurotransmitter Agents
Cholinergic Antagonists
Anti-Infective Agents, Urinary
Peripheral Nervous System Agents
Healthy
Cholinergic Agents
Mandelic Acids

Additional relevant MeSH terms:
Oxybutynin
Anti-Infective Agents
Parasympatholytics
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
Mandelic Acids

ClinicalTrials.gov processed this record on May 07, 2009