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

NCT01819870 | Unknown Phase 1

• 1 other identifier: 125HPS12006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension; Chronic Stable Angina; Congestive Heart Failure

Keywords

Carvedilol; Dilatrend SR capsule; Dilatrend Tablet; Pharmacokinetics; Healthy male subjects

Outcome Measures

Primary Outcomes (1)

• In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau

  AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 48 hours sample) determined using the linear trapezoidal rule

  0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)

Secondary Outcomes (6)

• In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCinf

  0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)

• In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,max

  0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)

• In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,min

  0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)

• In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Tss,max

  0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)

• In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg t½

  0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)

Study Arms (2)

Dilatrend SR capsule 32mg

EXPERIMENTAL

Drug: Dilatrend SR capsule 32mg

Dilatrend IR tablet 25mg

ACTIVE COMPARATOR

Drug: Dilatrend IR tablet 25mg

Interventions

Dilatrend SR capsule 32mg DRUG

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

Dilatrend SR capsule 32mg

Dilatrend IR tablet 25mg DRUG

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

Dilatrend IR tablet 25mg

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Kyungpook National University Hospital Clinical Trial Center

Daegu, Eok-dong 2(i)-ga Jung-gu, 700-721, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension; Angina, Stable; Heart Failure

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Young-Ran Yoon

  Kyungpook National University Hospital Clinical Trial Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Ran Yoon

CONTACT

053-420-4950; yry@knu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 28, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 1, 2013

Record last verified: 2013-01

Locations

KR (1)