NCT02477306

A Bioequivalence Study of Rabeprazole From Idiazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT)

Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Rabeprazole From Idiazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.

Conditions

• Healthy

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: 2014-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2015-06-22
• Last updated: 2015-06-22

Locations

1 site across 1 country: Egypt