NCT02605395

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

Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Rabeprazole From Raperazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT) After a Single Oral Dose Administration of Each to Healthy Adults Under Fed Conditions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions. In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1. PARIET is a registered trademark of EISAI Co. Limited.

Conditions

• Gastrointestinal Diseases

Interventions

Type	Name	Description
DRUG	IDIAZOLE 20mg DR tabs	IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
DRUG	PARIET 20 mg DR tabs	PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.

Timeline

• Start date: 2014-03-22
• Primary completion: 2014-03-30
• Completion: 2014-03-30
• First posted: 2015-11-16
• Last updated: 2018-10-01
• Results posted: 2018-10-01

Locations

1 site across 1 country: Egypt