Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
Overview[ - collapse ][ - ]
| 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 | Healthy |
| Intervention | Drug: Rabeprazole Sodium Tablets 20 mg Drug: Aciphex® Tablets 20 mg |
| Phase | Phase 1 |
| Sponsor | Mylan Pharmaceuticals |
| Responsible Party | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier | NCT00649493 |
| First Received | March 30, 2008 |
| Last Updated | November 23, 2009 |
| Last verified | November 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 30, 2008 |
|---|---|
| Last Updated Date | November 23, 2009 |
| Start Date | May 2003 |
| Estimated Primary Completion Date | June 2003 |
| Current Primary Outcome Measures | The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. [Time Frame: blood collections through 24 hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg |
|---|---|
| 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 |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label |
| Condition | Healthy |
| Intervention | Drug: Rabeprazole Sodium Tablets 20 mg 20mg, single dose fed Drug: Aciphex® Tablets 20 mg 20mg, single dose fed |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 72 |
| Estimated Completion Date | June 2003 |
| Estimated Primary Completion Date | June 2003 |
| Eligibility Criteria | Inclusion Criteria: - healthy, adult subjects, 18 years and older - able to swallow medication Exclusion Criteria: - institutionalized subjects - history of any significant disease - use of any prescription or OTC medications within 14 days of start of study - received any investigational products within 30 days prior to start of study |
| Gender | Both |
| Ages | 8 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00649493 |
|---|---|
| Other Study ID Numbers | RABE-0326 |
| 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 | November 2009 |
Locations[ + expand ][ + ]
| PRACS Institute, Ltd. | Fargo, North Dakota, United States, 58104 |
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