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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• Between 20 aged and 50 aged in healthy adults

• Weight more than 55kg, IBW 20% within the range

• Agreement with written informed consent

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

• 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