Fed Study of Oxybutynin Chloride Extended-Release Tablets 10 mg and Ditropan XL® Tablets 10 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00649727
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008
  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 an oral, single 20 mg (2 x 10 mg) dose under fed conditions.


Condition Intervention Phase
Healthy
Drug: Oxybutynin Chloride ER Tablets 10 mg
Drug: Ditropan XL® Tablets 10 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single-Dose Food In Vivo Bioequivalence Study of Oxybutynin Chloride Extended-Release Tablets (10 mg; Mylan) and Ditropan XL® Tablets(10 mg; ALZA) in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

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

Enrollment: 24
Study Start Date: July 2002
Study Completion Date: August 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oxybutynin Chloride ER Tablets 10 mg
Drug: Oxybutynin Chloride ER Tablets 10 mg
2x10mg, single dose fed
Active Comparator: 2
Ditropan XL® Tablets 10 mg
Drug: Ditropan XL® Tablets 10 mg
2x10mg, single dose fed

  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. oral contraceptives initiated at least 3 months prior to the start of the study and continued during the study, or
      2. 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
      3. barrier methods containing or used in conjunction with a spermicidal agent, or
      4. 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.
    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. 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, excluding hormonal contraceptives and hormonal replacement therapy initiated at least 3 months prior to study medication dosing.
    2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication, excluding hormonal contraceptives and hormonal replacement therapy initiated at least 3 months prior to study medication dosing.
  4. Diseases:

    1. History of any significant chronic disease and/or hepatitis.
    2. History of drug and/or alcohol abuse.
    3. Acute illness at the time of either the prestudy medical evaluation or dosing.
    4. Risk or history of urinary retention, gastric retention or narrow angle glaucoma.
    5. Positive HIV, Hepatitis B, or Hepatitis C test.
  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: NCT00649727

Locations
United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Thomas S Clark, M.D. Kendle International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Will Sullivan, Global Head of Product Risk and Safety Management, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00649727     History of Changes
Other Study ID Numbers: OXYB-0263
Study First Received: March 30, 2008
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Oxybutynin
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents

ClinicalTrials.gov processed this record on April 17, 2014