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

This study has been completed.

First Received on March 30, 2008. Last Updated on November 23, 2009 History of Changes

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:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Rabeprazole sodium

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

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 ]

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
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

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649493

Locations

United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Mylan Pharmaceuticals

Investigators

Principal Investigator:

James D Carlson, Pharm. D.

PRACS Institute Ltd.

More Information

Additional Information:

Mylan Pharmaceuticals Inc. - Clinical Trial Results This link exits the ClinicalTrials.gov site

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use This link exits the ClinicalTrials.gov site

Recalls, Market Withdrawals and Safety Alerts This link exits the ClinicalTrials.gov site

FDA Enforcement Report Index This link exits the ClinicalTrials.gov site

Medwatch, FDA Safety Information and Adverse Event Reporting Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier:	NCT00649493 History of Changes
Other Study ID Numbers:	RABE-0326
Study First Received:	March 30, 2008
Last Updated:	November 23, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012