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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00648349 |
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Rabeprazole Sodium Delayed-Release Tablets 20 mg Drug: Aciphex® Delayed-Release Tablets 20 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Rabeprazole Sodium Delayed-Release Tablets (20 mg; Mylan) to Aciphex® Delayed-Release Tablets (20 mg; Eisia) in Healthy Volunteers |
Enrollment: | 72 |
Study Start Date: | May 2003 |
Study Completion Date: | June 2003 |
Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Rabeprazole Sodium Delayed-Release Tablets 20 mg
|
Drug: Rabeprazole Sodium Delayed-Release Tablets 20 mg
20mg, single dose fasting
|
2: Active Comparator
Aciphex® Delayed-Release Tablets 20 mg
|
Drug: Aciphex® Delayed-Release Tablets 20 mg
20mg, single dose fasting
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and non-pregnant, non-lactating female
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:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | RABE-0325 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00648349 |
Health Authority: | United States: Institutional Review Board |
Healthy Rabeprazole |
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