Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

Stomach Ulcer Clinical Trial

Official title:

A Clinical Trial to Investigate the Influence of CYP2C19 Polymorphism on Pharmacokinetic/Pharmacodynamic Characteristics of Omeprazole in Healthy Korean Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299687
• Other study ID #: OMP_CYP2C19
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2014
• Last updated: December 31, 2014
• Start date: September 2014

Study information

• Verified date: December 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Food and Drug Administration: Republic of Korea
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Stomach Ulcer

Intervention

Drug:
• Omeprazole

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean and median Intragastric PH		24 hour	No
Secondary	AUC		12 hour	No
Secondary	Cmax		12 hour	No