An open-label, crossover clinical study to investigate the effects of Ojeoksan on the pharmacokinetics of Celecoxib capsules in healthy male volunteers
- Conditions
- Not Applicable
- Registration Number
- KCT0002447
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 26
1. Age: >= 20 and <= 45 years (at time of informed consent)
2 Body Weight(kg): >= 50 and <= 90 and BMI [body weight (kg) / height (m)2]: more than >= 18.0 and <= 27.0
3. Subjects who have given their written informed consent
4. Subjects who are reliable and willing to make themselves available for the duration of the study and follow the study protocol
1. History or clinical evidence of significant respiratory, cardiovascular, renal, gastrointestinal, hepatic, endocrine, hematologic, neurologic, psychiatric, or other chronic disease, alcoholism, or drug abuse
2. Present or previous significant drug allergy to any prescription (ex. celecoxib, sulfonamide, aspirin, other COX2 inhibitors, NSAIDs) or over-the-counter medication
3. Use of the following medications or products during the periods specified below:
- CYP2C9 inducers or inhibitors, within one month prior to scheduled study drug administration
- Any prescription drug, over-the-counter medication, or herbal medications within 14 days prior to scheduled study drug administration
- Alcohol and caffeine within 3 days prior to scheduled study drug administration
- Grapefruit or grapefruit products within 3 days prior to scheduled study drug administration
4. Participation in any other clinical trial within 12 weeks prior to scheduled study drug administration (measured from the final dosing day in the previous trial)
5. Donation of a unit of blood within two months, or of blood components within one month, or receipt of blood transfusion within one month before the first administration of the study drug
6. Subjects who test positive in serological tests and drug tests (serological tests for HBs antigen, HCV antibody, and HIV antibody; urine toxic screening for drug abuse)
7. Smokers or former smokers who have quit smoking within the previous one month or positive cotinine test result
8. Subjects who show the following results;
- Blood pressure: low blood pressure (SBP = 100 mmHg or DBP = 60 mmHg), high blood pressure (SBP = 150 mmHg or DBP = 100 mmHg) at screening period
- Liver function test: ALT, AST > 1.5 times of the upper limit of normal range
9. Alcohol abuse (regularly consuming > 21 units per week) and not stop drinking alcohol during the study period
10. Subjects who have a condition known to interfere with the absorption of study drug
11. Otherwise judged by the investigator to be inappropriate for inclusion in the study
12. Subjects who does not read and clearly understand the information presented
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast of Celecoxib;Cmax of Celecoxib
- Secondary Outcome Measures
Name Time Method AUCinf of Celecoxib ;Tmax of Celecoxib