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

Mylan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aciphex® Tablets 20 mg; Drug: Rabeprazole Sodium Tablets 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00649493

RABE-0326

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 8+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

1

Experimental group

Description:

Rabeprazole Sodium Tablets 20 mg

Treatment:

Drug: Rabeprazole Sodium Tablets 20 mg

2

Active Comparator group

Description:

Aciphex® Tablets 20 mg

Treatment:

Drug: Aciphex® Tablets 20 mg