Expired Study
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Fargo, North Dakota 58104


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.


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


Study is Available At:


Original ID:

RABE-0326


NCT ID:

NCT00649493


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

8 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mylan Pharmaceuticals


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

72


Enrollment Type:

Actual


Overall Contact Information

Official Name:James D Carlson, Pharm. D.
Principal Investigator
PRACS Institute Ltd.

Study Dates

Start Date:May 2003
Completion Date:June 2003
Completion Type:Actual
Primary Completion Date:June 2003
Primary Completion Type:Actual
Verification Date:November 2009
Last Changed Date:November 23, 2009
First Received Date:March 30, 2008

Study Outcomes

Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Rabeprazole Sodium Tablets 20 mg
Description:20mg, single dose fed
Arm Name:1
Intervention Type:Drug
Name:Aciphex® Tablets 20 mg
Description:20mg, single dose fed
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Rabeprazole Sodium Tablets 20 mg
Study Arm Type:Active Comparator
Arm Name:2
Description:Aciphex® Tablets 20 mg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Mylan Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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