KCT0002017
Completed
未知
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
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Dong-A University Hospital
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
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