Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00649259|
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Oxybutynin Chloride ER Tablets 10 mg Drug: Ditropan XL® Tablets 10 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Dose Food In Vivo Bioequivalence Study of Oxybutynin Chloride ER Tablets (10 mg; Mylan) and Ditropan XL® Tablets (10 mg; ALZA) in Healthy Volunteers|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||November 2002|
|Actual Study Completion Date :||November 2002|
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
- Bioequivalence [ Time Frame: within 30 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Age: 18 years and older.
Sex: Male and/or non-pregnant, non-lactating female
- 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.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
- 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
- barrier methods containing or used in conjunction with a spermicidal agent, or
- postmenopausal accompanied with a documented postmenopausal course of at least one year or surgical sterility (tubal ligation, oophorectomy or hysterectomy).
- 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.
- 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).
- 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.
- Institutionalized subjects will not be used.
- Use of any tobacco products.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
- Any recent, significant change in dietary or exercise habits.
- Positive test for any drug included in the urine drug screen.
- Use of any medication within the 14 days prior to the initial dose of study medication. Hormonal contraceptives and hormonal replacement therapy should NOT be used within 3 months prior to study medication dosing.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- History of any significant chronic disease and/or hepatitis.
- History of drug and/or alcohol abuse.
- Acute illness at the time of either the prestudy medical evaluation or dosing.
- Risk or history of urinary retention, gastric retention or narrow angle glaucoma.
- Positive HIV, Hepatitis B, or Hepatitis C test.
Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing.
- Donation or loss of a significant volume of blood or plasma (> 450 ml) within 28 days prior to the initial dose of study medication.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to oxybutynin chloride or any other anticholinergics.
- History of difficulty in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit-containing products within 7 days of study drug administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649259
|United States, West Virginia|
|Kendle International Inc.|
|Morgantown, West Virginia, United States, 26505|
|Principal Investigator:||Thomas S Clark, M.D.||Kendle International Inc.|
|Responsible Party:||Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.|
|Other Study ID Numbers:||
|First Posted:||April 1, 2008 Key Record Dates|
|Last Update Posted:||April 1, 2008|
|Last Verified:||March 2008|
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action