A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers
A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers.
Inclusion Criteria:
Exclusion Criteria:
Subject has hypersensitivity reaction or clinically significant history about investigational drug
Clinically significant cardiovascular system, respiratory system, liver, renal, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease and so on
Inadequate result of laboratory test
Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 210 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
Creatinine clearance < 80ml/min
Subject with known for history(such as gastrointestinal disease or operation) with affect the absorption of drug
Subject takes an abnormal meal which affect the ADME of drug
Previously participated in other trial within 90 days
Previously make whole blood donation within 60 days or component blood donation within 30 days
Subject with positive reaction for reason of laboratory test result
An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Daegu, Seoul 700-721, South Korea