Completed

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

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What is being tested

Ilaprazole

Drug
Who is being recruted

From 20 to 45 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: January 2009
See protocol details

Summary

Principal SponsorInje University
Last updated: September 20, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

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

NCT01688544
Principal SponsorInje University
Last updated: September 20, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
No congenital or acquired chronic disease
appropriate for the study judging from examinations (hematology, chemistry, urinalysis and so on), vital sign and ECG results
healthy adult volunteer between 20 and 45 years of age and within 20% of ideal body weight
sign the informed consent form prior to study participation
7 exclusion criteria prevent from participating
abnormal laboratory results
alcohol or drug abuser
donated whole blood within 60days prior to the study
history of hypersensitivity against drugs or clinically significant allergic diseases
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Inje University Busan Paik Hoapital Clinical Trial Center

Busan, South KoreaOpen Inje University Busan Paik Hoapital Clinical Trial Center in Google Maps
CompletedOne Study Center