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

Inje University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ilaprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01688544

08-112

Details and patient eligibility

About

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.

Full description

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

Enrollment: 27 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Ilaprazole

Experimental group

Description:

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

Treatment:

Drug: Ilaprazole