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Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety

Healthy Clinical Trial

Official title:
A Phase 1, Randomized, Open-Label, Four-Period Crossover, Multiple-Dose, Single-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety Following Administration of Oral Doses of 10, 20 and 40 mg of Ilaprazole and 40 mg of Esomeprazole in Healthy Subjects

Clinical Trial Summary

The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1) and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg, 20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days; and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5 following QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg esomeprazole tablets for 5 consecutive days.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01820143
Study type Interventional
Source Il-Yang Pharm. Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date February 2005
Completion date April 2005
View Details
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