A study for estimation of predictive factors which are related with drug response variability of COX-2 selective inhibitor in Korean healthy subjects
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0003958
- Lead Sponsor
- Dong-A University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 24
1. A subject who meets the standards of SCR completion among the participants who took part in the previous study (14-071) and completed the gene examination of four types of SNP
2. Healthy man aged between 19 and 50 (inclusive) at the time of the screening
3. A subject with a body weight over 55 kg (inclusive) and with body mass index (BMI) between 18 (inclusive) and 30 (inclusive)
4. A subject who is willing to make himself available for the study period and follow the study protocol and provides written informed consent after fully understanding the study procedures
1. A subject who has any clinically significant past or present medical history of liver disease, kidney disease, nervous system disease, respiratory system disease, endocrine system disease, hemato-oncology disease, urinary system disease, cardiovascular system disease, musculoskeletal system disease or mental disorder
2. A subject with past history of gastrointestinal disease (e.g., Crohn’s disease, ulcer, acute or chronic pancreatitis, and others) or surgery (except for simple appendectomy or repair of a hernia, endoscopic submucous resection and endoscopic polypectomy), which can influence the absorption of investigational product.
3. A subject with any hypersensitivity to drugs including celecoxib and other drugs (e.g., aspirin, antibiotics, and others) or any history of clinically significant hypersensitivity
4. A subject with any clinically significant findings in ECG at the time of screening as follows: QTc> 450 msec, PR interval > 200 msec; QRS duration > 120
5. A subject who has the following vital signs results in sitting position after he rests for at least 3 minutes at the time of the screening :
SBP = 100 mmHg or DBP = 60 mmHg; SBP = 160 mmHg or DBP = 95 mmHg
6. A subject who has taken any ethical-the-counter drug or herbal compound within 2 weeks prior to the administration of the study drug or has taken any over-the-counter drug or vitamin supplement within 1 week before the investigational product administration (If, however, the drugs are determined not to be effective in pharmacokinetic profiles, the subjects can participate in the study according to the judgment of the investigator.).
7. A subject who has participated in any other clinical and had medication within 2 months prior to the first administration of investigational product (If five times the pharmacokinetic half-life of the medication passes, the subject can participate in the study).
8. A subject who has donated whole blood within 2 months or blood components within 1 month or received a blood transfusion within 1 month prior to the administration of investigational product.
9. A subject who consistently drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or is not able to stop drinking throughout the clinical trial.
10. A smoker who consumes more than 10 cigarettes on average a day for recent 3 months and who is unable to stop smoking during the study.
11. A subject who eats or drinks products containing grapefruit and who is unable to stop eating or drinking throughout the study period, from 48 hours before the first administration to the post-study visit.
12. A subject who takes or who is unable to stop eating or drinking products containing caffeine (coffee, green tea, black tea, soda, coffee flavored milk, nutritious tonic, and others) from 24 hours prior to the administration to the point of discharge
13. A subject who is not eligible for the study due to clinical laboratory results or other reasons on the investigators’ judgment.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Celecoxib's AUClast, Cmax;Lipopolysaccharide induced by COX-2 (Cyclooxygenase-2) activity assay;COX-2 (Cyclooxygenase-2) mRNA and protein assay;COX-1 (Cyclooxygenase-1) activity assay (TXB2);Light transmittance aggregometry (% of inhibition)
- Secondary Outcome Measures
Name Time Method Celecoxib's AUCinf, Tmax, t1/2, CL/F, Vd/F;AChE (Acetylcholineesterase) activity;BChE (Butyrylcholinesterase) activity;PON-1 (Paraoxonase/arylesterase-1) activity