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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chong Kun Dang Pharmaceutical
Age
20–50
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Between 20 aged and 50 aged in healthy adults
Weight more than 55kg, IBW 20% within the range
Agreement with written informed consent
You may not be if
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
* AST(SGOT) or ALT(SGPT) \> 1.5 x upper limit of normal range
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
Clareo Health | 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
