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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01688544

Enrollment

Registered

2012-09-20

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2012-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Ilaprazole, Intragastric pH, Serum Gastrin, Pharmacokinetics

Brief summary

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

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

Interventions

DRUGIlaprazole

Ilaprazole 10 mg for 7 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
24 hour intragastric ph	After 7 days dosing of Ilaprazole 10 mg

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026