NCT02529787

A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA)

Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg DR Capsules (Takeda Pharmaceuticals America Inc., USA)

• 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 Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)

Detailed description

Primary Pharmacokinetic Parameters: Cmax, Area under cover (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	Doxirazole	1 capsule contains 60 mg Dexlansoprazole
DRUG	Dexilant	1 capsule contains 60 mg Dexlansoprazole

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2015-08-20
• Last updated: 2015-08-20

Locations

1 site across 1 country: Egypt