Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
Sponsor
Mylan Pharmaceuticals Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00649493
Collaborator
(none)
72
1
2
1
70.7
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
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
Study Start Date
:
May 1, 2003
Actual Primary Completion Date
:
Jun 1, 2003
Actual Study Completion Date
:
Jun 1, 2003
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Rabeprazole Sodium Tablets 20 mg |
Drug: Rabeprazole Sodium Tablets 20 mg
20mg, single dose fed
|
Active Comparator: 2 Aciphex® Tablets 20 mg |
Drug: Aciphex® Tablets 20 mg
20mg, single dose fed
|
Outcome Measures
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. [blood collections through 24 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
8 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | PRACS Institute, Ltd. | Fargo | North Dakota | United States | 58104 |
Sponsors and Collaborators
- Mylan Pharmaceuticals Inc
Investigators
- Principal Investigator: James D Carlson, Pharm. D., PRACS Institute Ltd.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Mylan Pharmaceuticals Inc. - Clinical Trial Results
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
- Recalls, Market Withdrawals and Safety Alerts
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00649493
Other Study ID Numbers:
- RABE-0326
First Posted:
Apr 1, 2008
Last Update Posted:
Nov 25, 2009
Last Verified:
Nov 1, 2009
Additional relevant MeSH terms: