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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2003-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Food Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Tablets 20 mg

NCT00649194

Healthy

COMPLETED PHASE1

Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg

NCT00648349

Healthy

COMPLETED PHASE1

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fed Conditions

NCT01990586

Healthy

COMPLETED PHASE1

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fasted Conditions

NCT01990378

Healthy

COMPLETED PHASE1

Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions

NCT02605395

Gastrointestinal Diseases

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Rabeprazole Sodium Tablets 20 mg

Group Type EXPERIMENTAL

Rabeprazole Sodium Tablets 20 mg

Intervention Type DRUG

20mg, single dose fed

2

Aciphex® Tablets 20 mg

Group Type ACTIVE_COMPARATOR

Aciphex® Tablets 20 mg

Intervention Type DRUG

20mg, single dose fed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rabeprazole Sodium Tablets 20 mg

20mg, single dose fed

Intervention Type DRUG

Aciphex® Tablets 20 mg

20mg, single dose fed

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes