Clinical trial NCT02299687: Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole
Official title: A Clinical Trial to Investigate the Influence of CYP2C19 Polymorphism on Pharmacokinetic/Pharmacodynamic Characteristics of Omeprazole in Healthy Korean Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stomach Ulcer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers


Eligibility criteria: Inclusion Criteria:

1. Are able to provide written informed consent.
2. The subject is a healthy Korean aged 20 to 45 years, inclusive.
3. The subject weighs at least 55 (for female, 55) to 90 kg and has a body mass index (BMI) range of 18 to 25 kg/m2

Exclusion Criteria:

1. Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
2. Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
3. Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
4. Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
5. Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
6. Subject who have history of allergy on omeprazole
7. Subject who can not continue proper contraception method during study period.
8. Subject with a positive urine HCG test result on screening. (in case of woman subject)
9. Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period
10. Subjects who consume more than 10 cigarette per day or who are unable to abstain from smoking during the PK/PD testing period
11. Subjects who are unable to abstain from grapefruit or caffeine containing food 3 day prior the first administration of the investigational product
12. Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.

Primary outcomes:
measure: mean and median Intragastric PH
timeFrame: 24 hour
Secondary outcomes:
measure: AUC
timeFrame: 12 hour
measure: Cmax
timeFrame: 12 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Park S, Hyun YJ, Kim YR, Lee JH, Ryu S, Kim JM, Oh WY, Na HS, Lee JG, Seo DW, Hwang IY, Park Z, Jang IJ, Oh J, Choi SE. Effects of CYP2C19 Genetic Polymorphisms on PK/PD Responses of Omeprazole in Korean Healthy Volunteers. J Korean Med Sci. 2017 May;32(5):729-736. doi: 10.3346/jkms.2017.32.5.729.