Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR Capsule 32mg and Dilatrend Tablet 25mg

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare the pharmacokinetic characteristics and safety of dilatrend SR capsule 32mg and Dilatrend tablet 25mg in healthy male subjects.

• 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 35aged in healthy male

• Body Weight more than 50kg, and within 20% of ideal body weight(IBW).

• IBW(kg) = {height(cm)-100}*0.9

• Have not any congenital or chronic disease and medical symptoms.

• Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.

• Agreement with written informed consent

Exclusion Criteria:

• Subject has hypersensitivity reaction or clinically significant history about carvedilol or investigator drug.

• Clinically significant cardiovascular system, respiratory system, liver, kidney, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease, otorhinolaryngologic diseases and so on.

• Hypotension(SBP < 105mmHg or DBP < 65mmHg), Hypertension(SBP > 150mmHg or DBP > 100mmHg)

• Heart rate < 50times/minute

• Active liver disease or AST, ALT > 1.5*upper limit of normal range

• Creatinine clearance < 80mL/min

• Subject has a disease affecting drug's ADME or gastrointestinal surgery.

• Subject with symptoms of injured or acute disease within 28days before the first IP administration.

• Subject has a history of drug abuse or a positive reaction for drug abuse at the screening test for urine.

• Taking ETC medicine including oriental medicine within 14days before the first IP administration or Taking OTC medicine within 7days

• Subject takes an abnormal meal which affect the ADME of drug.

• Previously participate in other trial within 90days.

• Previously make whole blood donation within 60days or component blood donation within 30days before the first IP administration.

• Continued to be taking caffeine(caffeine > 5cup/day), drinking(alcohol > 21unit/week, 1unit = 10g = 12.5mL of pure alcohol) or during clinical trials can not be drunk or severe heavy smoker(cigarette > 10cigarettes/day).

• Subject with positive reaction about serum test(HBsAg, HCV Ab, HIV Ag/Ab, VDRL)

• Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption.

• An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result.