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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649493 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Rabeprazole Sodium Tablets 20 mg Drug: Aciphex® Tablets 20 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment |
| 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 |
| 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 Tablets 20 mg
|
Drug: Rabeprazole Sodium Tablets 20 mg
20mg, single dose fed
|
|
2: Active Comparator
Aciphex® Tablets 20 mg
|
Drug: Aciphex® Tablets 20 mg
20mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 8 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:
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James D Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullivan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | RABE-0326 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649493 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents |
Enzyme Inhibitors Pharmacologic Actions Rabeprazole |