Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00649493
First received: March 30, 2008
Last updated: November 23, 2009
Last verified: November 2009

March 30, 2008
November 23, 2009
May 2003
June 2003   (final data collection date for primary outcome measure)
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 ]
Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00649493 on ClinicalTrials.gov Archive Site
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Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Rabeprazole Sodium Tablets 20 mg
    20mg, single dose fed
  • Drug: Aciphex® Tablets 20 mg
    20mg, single dose fed
  • Experimental: 1
    Rabeprazole Sodium Tablets 20 mg
    Intervention: Drug: Rabeprazole Sodium Tablets 20 mg
  • Active Comparator: 2
    Aciphex® Tablets 20 mg
    Intervention: Drug: Aciphex® Tablets 20 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
June 2003
June 2003   (final data collection date for primary outcome measure)

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
Both
8 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00649493
RABE-0326
Not Provided
Wayne Talton, Mylan Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: James D Carlson, Pharm. D. PRACS Institute Ltd.
Mylan Pharmaceuticals
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP