Fasting Study of Oxybutynin Chloride Extended-Release Tablets 5 mg and Ditropan XL® Tablets 5 mg
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Oxybutynin Chloride Extended-release Tablets 5 mg (Drug); Ditropan XL® Tablets 5 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s): James D Carlson, Pharm. D., Principal Investigator, Affiliation: PRACS Institute Ltd.
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 a single, oral 20 mg (4 x 5 mg) dose under fasting conditions.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
PRACS Institute, Ltd., Fargo, North Dakota 58104, United States
Additional Information
Mylan Pharmaceuticals Inc. - Clinical Trial Results Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use Recalls, Market Withdrawals and Safety Alerts FDA Enforcement Report Index Medwatch, FDA Safety Information and Adverse Event Reporting Program
Starting date: December 2002
Last updated: March 31, 2008
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