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Clinical Trials/NCT00649493
NCT00649493CompletedPhase 1

Single-Dose Food In Vivo Bioequivalence Study of Rabeprazole Sodium Tablets (20 mg; Mylan) and Aciphex® Tablets (20 mg; Eisai) in Healthy Volunteers

Mylan Pharmaceuticals Inc1 site in 1 country72 target enrollmentStarted: May 2003Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
72
Locations
1
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
8 Years to — (Child, Adult, Older Adult)
Sex
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

Arms & Interventions

1

Experimental

Rabeprazole Sodium Tablets 20 mg

Intervention: Rabeprazole Sodium Tablets 20 mg (Drug)

2

Active Comparator

Aciphex® Tablets 20 mg

Intervention: Aciphex® Tablets 20 mg (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (1)

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