A randomized, open-label, three-way crossover clinical trial to compare safety and pharmacokinetic characteristics after single administration of Carol-F Tab, Advil Liqui-Gels and Brufen Tab 200 mg in healthy male volunteers
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0002017
- Lead Sponsor
- Dong-A University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 36
(1) Healthy man aged between 19(inclusive) and 50(inclusive) at the time of the screening
(2) A subject with a body weight over 50 kg (inclusive) and with body mass index (BMI) between 18.5 (inclusive) and 27 (inclusive)
(3) A subject who has no congenital disease, no chronic disease requiring treatment, np symptoms of illness and no medical opinions after a medical examination
(4) Suitable subject who has considered eligible for the clinical trial based on the results from the clinical laboratory tests including hematology, blood chemistry, serology and urinalysis which were set up and conducted according to the characteristics of the investigational products during the screening
(5) A subject who is willing to make himself available for the study period and follow the study protocol, and is able to provide written informed consent after fully understanding the study procedures.
(1) A subject who has any clinically significant 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, or any medical histories as follows
1) Peptic ulcer
2) Severe blood disease
3) Asthmatic bronchitis
4) Treatment of pain occurring after coronary artery bypass graft (CABG)
5) Myocardial infarction
6) Heart failure
(2) A subject with any history of gastrointestinal disease (e.g., Crohn’s disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products.
(3) A subject with hypersensitivity of drugs including Ibuprofen and other drugs (e.g., aspirin, antibiotics, and others) or any history of clinically significant hypersensitivity (e.g., photoallergy, phototoxicity, and others).
(4) A subject who has the following clinical laboratory test results
? Liver Function Test (AST, ALT) > three times the upper limit of the normal range
? eGFR < 60 ml/min/1.73 m2 calculated by MDRD (Modification of Diet in Renal Disease)
(5) A subject who has the following vital signs results in sitting position at the time of the screening :
SBP = 90 mmHg or DBP = 60 mmHg; SBP = 150 mmHg or DBP = 100 mmHg
(6) A subject with a history of drug abuse or a positive urine drug screening for drug abuse
(7) A subject who has taken any ethical-the-counter drug, herbal compound (including cyclosporine, aspirin, and others) or has taken any methotrexate, anticoagulant drug (e.g., warfarin), antihypertensive drug, diuretics and others which can be pharmacologically affected by investigational products within 2 weeks prior to the administration of investigational products, 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 characteristics, the subjects can participate in the study according to the judgment of the investigator.).
(8) A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product. (The end date of another clinical trial is based on the last day of the administration)
(9) 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 investigational product administration.
(10) A subject who consistently drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or does not abstain from drinking throughout the clinical trial.
(11) A smoker who consumes more than 10 cigarettes on average a day for recent 3 months and who is unable to stop smoking from 48 hours before the administration of investigational products to the last point for blood sampling.
(12) 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.
(13) 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 48 hours prior to the administration of each study period to the last point f
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ibuprofen's AUC0-t, Cmax, Tmax
- Secondary Outcome Measures
Name Time Method Ibuprofen's AUCinf, t1/2, CL/F