Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study
Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study
To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.
Inclusion Criteria:
Exclusion Criteria:
Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects 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
Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
Inadequate laboratory test result
Clinically significant allergic disease(except for mild allergic rhinitis is not needed medication)
Subject with known for hypersensitivity reactions to glitazones or sulfonylureas
Previously participated in other trial within 60 days
Medication with drug-mediated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
Subject has taken abnormal meals which affects the ADME of drug
Impossible to taking the institutional standard meal
Previously donate whole blood within 60 days or component blood within 20 days
Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
An impossible one who participates in clinical trial by investigator's decision including laboratory test result