Official Title: “Single-Dose Food In Vivo Bioequivalence Study of Rabeprazole Sodium Tablets (20 mg; Mylan) and Aciphex® Tablets (20 mg; Eisai) in Healthy Volunteers”

The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment

Study Primary Completion Date: June 2003

Intervention(s) in this Clinical Trial

• Drug: Rabeprazole Sodium Tablets 20 mg
  • 20mg, single dose fed
• Drug: Aciphex® Tablets 20 mg
  • 20mg, single dose fed

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Rabeprazole Sodium Tablets 20 mg
• Active Comparator: 2
  • Aciphex® Tablets 20 mg

Primary Measures

• Bioequivalence
  • Time Frame: within 30 days
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mylan Pharmaceuticals

Overall Clinical Trial Officials and Contacts

James D Carlson, Pharm. D. Principal Investigator PRACS Institute Ltd.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00649493

Study ID Number: RABE-0326

ClinicalTrials.gov Identifier: NCT00649493

Health Authority: United States: Institutional Review Board

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