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

Study Overview
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Brief Summary
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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
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Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in healthy Korean volunteers

Official Title
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Phase 1 Study to Evaluate the Effect of CYP Polymorphism and Gender on the Pharmacokinetics and Pharmacodynamics of Ilaprazole After Multiple Dosing

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ilaprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilaprazole<br>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 | Drug: Ilaprazole<br>* Ilaprazole 10 mg for 7 days<br>* Other names: 5-(1H-pyrrol-1yl)-1H-benzimidazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour intragastric ph |  | After 7 days dosing of Ilaprazole 10 mg | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite |  | After 7 days dosing of Ilaprazole | 
| Serum Gastrin level |  | After 7 days dosing of Ilaprazole | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ilaprazole, Intragastric pH, Serum Gastrin, Pharmacokinetics