Skip to main content
OpenTrials
Completed

NCT Number: NCT01688544

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Paik Hoapital Clinical Trial Center

Busan, 614-735, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ilaprazole

Drug

Ilaprazole 10 mg for 7 days

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

Primary outcomes

  1. 24 hour intragastric ph

    Time frame: After 7 days dosing of Ilaprazole 10 mg

Secondary outcomes

  1. Pharmacokinetic parameters (Cmax, AUC) of Ilaprazole and its metabolite

    Time frame: After 7 days dosing of Ilaprazole

  2. Serum Gastrin level

    Time frame: After 7 days dosing of Ilaprazole

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 20, 2012
Registry last updated
Sep 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.