Microdose drug-drug interaction study to evaluate the effect of rifampin on the pharmacokinetics of omeprazole
- Conditions
- Not Applicable
- Registration Number
- KCT0002203
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 6
1. Healthy male Korean subject age 19 to 45 at the screening visit
2. Subject who is over 55kg and as a result of calculated Ideal Body Weight, subject who is within the range of ±20%
3. After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice
1. history or clinical manifestation of clinically significant cardiovascular, respiratory, renal, endocrine, hematologic, digestive, central nervous, psychiatric disorder or malignant tumor;
2. history of gastrointestinal tract disease (Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of fluconazole and omeprazole
3. significant hypersensitive or clinically significant hypersensitivity reactions to any drug compound or other azole medicines or additives
4. determined as not appropriate for study participant during healthy examination (medical history, physical exam, lab test, vital sign) at screening
5. abnormalities in laboratory test
- AST or ALT > 1.5x upper limit of normal [ULN]
- Total bilirubin > 1.5x ULN
- CPK > 1.5x ULN
6. After resting for more than 5 minutes, systolic blood pressure =140 mmHg or =90 mmHg, diastolic blood pressure =90 mmHg or =60 mmHg in
7. history of drugs abuse
8. consumption of excessive caffeine, alcohol, and cigarette (caffeine: 5 cups/day, alcohol: 210g/week, cigarette: >10/day)
9. use of other clinical trial's investigational drug within 90 days prior to investigational study drug administration
10. use of drug metabolizing enzyme inducers or inhibitors such as barbiturates within 30 days prior to investigational study drug administration
11. donation of blood from 60 days or plasma from 30 days prior to investigational study drug administration
12. consumption of grapefruit-containing foods and beverages within 7 days prior to investigational study drug administration
13. use of any prescription medicines or herbal medicines within 14 days prior to investigational study drug administration or over-the-counter or vitamin preparations within 7 days before prior to investigational study drug administration
14. ineligible for participation in clinical trials due to other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUClast for omeprazole
- Secondary Outcome Measures
Name Time Method AUCinf, tmax, t1/2 for omeprazole