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

NCT ID: NCT01688544

Last Updated: 2012-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

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

Conditions

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Healthy

Keywords

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Ilaprazole Intragastric pH Serum Gastrin Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ilaprazole

Intervention Type DRUG

Ilaprazole 10 mg for 7 days

Interventions

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Ilaprazole

Ilaprazole 10 mg for 7 days

Intervention Type DRUG

Other Intervention Names

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2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl- 5-(1H-pyrrol-1yl)-1H-benzimidazole

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Jae-Gook Shin

Department of Pharmacology and Pharmacogenomics Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JaeGook Shin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

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Inje University Busan Paik Hoapital Clinical Trial Center

Busan, Busan, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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08-112

Identifier Type: -

Identifier Source: org_study_id