Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects
Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects
The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject.
And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.
Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs. fasting), two-period, two sequence crossover.
Every time before and after each medication, PK parameters and safety of CKD-501 1mg is performed using a blood sample and conducting some tests respectively.
Inclusion Criteria:
Exclusion Criteria:
Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) with affect the ADME of drug
Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy disease
Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
Inadequate result of laboratory test
Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
Subject with known for hypersensitivity reactions to glitazone
Previously participated in other trial within 60 days
Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
Subject takes an abnormal meal which affect the ADME of drug
Not able to taking the institutional standard meal
Previously make whole blood donation within 60 days or component blood donation within 20 days
Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Subject who not practice contraception during clinical trial or pregnant women(including positive pregnancy test) or nursing mothers