Pharmacokinetic/Pharmacodynamic Study of Ilaprazole to Evaluate the Effect of CYP Genetic Polymorphism

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ilaprazole

• Registration Number: NCT01688544
• Lead Sponsor: Inje University

Brief Summary

Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics of Ilaprazole.

Detailed Description

Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in healthy Korean volunteers

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-06
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-19
• Last Update Submitted: 2012-09-19
• Study First Posted: 2012-09-20
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• healthy adult volunteer between 20 and 45 years of age and within 20% of ideal body weight
• No congenital or acquired chronic disease
• appropriate for the study judging from examinations (hematology, chemistry, urinalysis and so on), vital sign and ECG results
• sign the informed consent form prior to study participation

Exclusion Criteria

• received any metabolizing enzymes or transporters inducing or inhibiting drugs like barbiturates within 1 month prior to the date of first drug administration
• history of hypersensitivity against drugs or clinically significant allergic diseases
• abnormal laboratory results
• positive result for helicobacter pylori infection from the Urea Breath Test
• alcohol or drug abuser
• pregnant or lactating
• donated whole blood within 60days prior to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ilaprazole	Ilaprazole	Before Ilaprazole dosing, 24 hours intragastric pH monitoring is performed as baseline value. After 7 days dosing of Ilaprazole 10 mg, 24 hours intragastric pH monitoring, serum gastrin level check, and pharmacokinetic sampling is performed

Primary Outcome Measures

Name	Time	Method
24 hour intragastric ph	After 7 days dosing of Ilaprazole 10 mg

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite	After 7 days dosing of Ilaprazole
Serum Gastrin level	After 7 days dosing of Ilaprazole

Trial Locations

Locations (1)

Inje University Busan Paik Hoapital Clinical Trial Center; 🇰🇷 Busan, Korea, Republic of