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Completed

NCT Number: NCT02299687

Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

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

Completed

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Key information

Conditions

Stomach Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are able to provide written informed consent.
  • The subject is a healthy Korean aged 20 to 45 years, inclusive.
  • 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

  • Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
  • Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
  • Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
  • 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.)
  • 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
  • Subject who have history of allergy on omeprazole
  • Subject who can not continue proper contraception method during study period.
  • Subject with a positive urine HCG test result on screening. (in case of woman subject)
  • 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
  • Subjects who consume more than 10 cigarette per day or who are unable to abstain from smoking during the PK/PD testing period
  • Subjects who are unable to abstain from grapefruit or caffeine containing food 3 day prior the first administration of the investigational product
  • Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.

Treatment and study plan

Omeprazole

Drug

Primary outcomes

  1. mean and median Intragastric PH

    Time frame: 24 hour

Secondary outcomes

  1. AUC

    Time frame: 12 hour

  2. Cmax

    Time frame: 12 hour

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
First posted
Nov 24, 2014
Registry last updated
Jan 1, 2015

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.

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