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

Chong Kun Dang

Status and phase

Unknown

Phase 1

Conditions

Essential Hypertension

Chronic Stable Angina

Congestive Heart Failure

Treatments

Drug: Dilatrend IR tablet 25mg

Drug: Dilatrend SR capsule 32mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01819870

125HPS12006

Details and patient eligibility

About

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.

Full description

Healthy male subjects are administrated multiple-dose over the period I and II (Crossover) of dilatrend SR capsule 32mg and dilatrend tablet 25mg.

Enrollment

48 estimated patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.