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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2002-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00649259

Healthy

COMPLETED PHASE1

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

NCT00649129

Healthy

COMPLETED PHASE1

Food Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg

NCT00648843

Healthy

COMPLETED PHASE1

Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg

NCT00649272

Healthy

COMPLETED PHASE1

Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg

NCT00650481

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Oxybutynin Chloride ER Tablets 10 mg

Group Type EXPERIMENTAL

Oxybutynin Chloride ER Tablets 10 mg

Intervention Type DRUG

2x10mg, single dose fed

2

Ditropan XL® Tablets 10 mg

Group Type ACTIVE_COMPARATOR

Ditropan XL® Tablets 10 mg

Intervention Type DRUG

2x10mg, single dose fed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxybutynin Chloride ER Tablets 10 mg

2x10mg, single dose fed

Intervention Type DRUG

Ditropan XL® Tablets 10 mg

2x10mg, single dose fed

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes