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

NCT ID: NCT01819870

Last Updated: 2013-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-08-31

Brief 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.

Detailed Description

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

Conditions

Essential Hypertension; Chronic Stable Angina; Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dilatrend SR capsule 32mg

Group Type: EXPERIMENTAL

Dilatrend SR capsule 32mg

Intervention Type: DRUG

• 1 capsule, oral, once daily, 7days
• over the period I&II(crossover)

Dilatrend IR tablet 25mg

Group Type: ACTIVE_COMPARATOR

Dilatrend IR tablet 25mg

Intervention Type: DRUG

• 1 tablet, oral, once daily, 7days
• over the period I&II(crossover)

Interventions

Dilatrend SR capsule 32mg

• 1 capsule, oral, once daily, 7days
• over the period I&II(crossover)

Intervention Type: DRUG

Dilatrend IR tablet 25mg

• 1 tablet, oral, once daily, 7days
• over the period I&II(crossover)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young-Ran Yoon

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital Clinical Trial Center

Locations

Kyungpook National University Hospital Clinical Trial Center

Daegu, Eok-dong 2(i)-ga Jung-gu, South Korea

Countries

South Korea

Central Contacts

Young-Ran Yoon

Role: CONTACT

yry@knu.ac.kr

053-420-4950

Other Identifiers

125HPS12006

Identifier Type: -

Identifier Source: org_study_id