Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg | RxWiki

Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg

Overview[ - collapse ][ - ]

Purpose	The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets relative to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.
Condition	Healthy
Intervention	Drug: Rabeprazole Sodium Delayed-Release Tablets 20 mg Drug: Aciphex® Tablets 20 mg
Phase	Phase 1
Sponsor	Mylan Pharmaceuticals
Responsible Party	Mylan Pharmaceuticals
ClinicalTrials.gov Identifier	NCT00649194
First Received	March 30, 2008
Last Updated	March 31, 2008
Last verified	March 2008

Tracking Information[ + expand ][ + ]

First Received Date	March 30, 2008
Last Updated Date	March 31, 2008
Start Date	August 2003
Estimated Primary Completion Date	August 2003
Current Primary Outcome Measures	Bioequivalence [Time Frame: within 30 days] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg
Official Title	Single-Dose Food In Vivo Bioequivalence Study of Rabeprazole Sodium Delayed-Release Tablets (20 mg; Mylan) to Aciphex® Tablets (20 mg; Eisai) in Healthy Volunteers
Brief Summary	The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets relative to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Condition	Healthy
Intervention	Drug: Rabeprazole Sodium Delayed-Release Tablets 20 mg 20mg, single dose fed Drug: Aciphex® Tablets 20 mg 20mg, single dose fed
Study Arm (s)	Experimental: 1 Rabeprazole Sodium Delayed-Release Tablets 20 mg Active Comparator: 2 Aciphex® Tablets 20 mg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	72
Estimated Completion Date	August 2003
Estimated Primary Completion Date	August 2003
Eligibility Criteria	Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior to dosing of each study period. If dosing is scheduled for a Sunday or Monday, the beta-HCG pregnancy test should be given within 48 hours prior to dosing for that study period. An additional 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. No hormonal contraceptives or hormonal replacement therapy are permitted in this 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. surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year. 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 men and 48 kg (106 lbs) for women and all subjects 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, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, 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. 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 cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic 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. 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 rabeprazole, any of the inactive ingredients, or other related products. 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption. 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00649194
Other Study ID Numbers	RABE-0340
Has Data Monitoring Committee	Not Provided
Information Provided By	Mylan Pharmaceuticals
Study Sponsor	Mylan Pharmaceuticals
Collaborators	Not Provided
Investigators	Principal Investigator: James D Carlson, Pharm. D. PRACS Institute Ltd.
Verification Date	March 2008

Locations[ + expand ][ + ]