NCT02446483

A Bioequivalence Study of Idiazole 20mg DR Tabs and PARIET® 20 mg DR Tabs After a Single Oral Dose Administration Under Fasting Conditions in Healthy Adults

Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Rabeprazole From Idiazole 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 Fasting Conditions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (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-period crossover study, separated by 7 days washout interval from the first study drug administration. In this study, the bioavailability of Rabeprazole from Idiazole 20 milligram (mg) delayed release (DR) tablets and PARIET 20 mg DR tablets after a single oral dose administration of each to healthy adults under fasting conditions, will be investigated by determining the 90% confidence limits for the log-transformed ratio (Test product / Reference product) for the bioequivalence parameters. The influence of sequence, product and period effect will be tested by analysis of variance (ANOVA). In this study a total of 60 subjects plus 1-4 additional subjects will be enrolled and split into two groups (Group A and B) of 30 each. For each subject, a total of 33 blood draws will be done and the volume of blood will not exceed 300 milliliters (mL) for the study. PARIET is a registered trademark of EISAI Co. Limited.

Conditions

• Gastrointestinal Diseases

Interventions

Type	Name	Description
DRUG	Idiazole 20mg DR tabs	Delayed release tablets containing 20 mg of rabeprazole
DRUG	PARIET 20 mg DR tabs	Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.

Timeline

• Start date: 2014-03-19
• Primary completion: 2014-03-26
• Completion: 2014-03-26
• First posted: 2015-05-18
• Last updated: 2017-11-17
• Results posted: 2017-06-14

Locations

1 site across 1 country: Egypt