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

A Randomized, Open-label, Multiple-dose, Crossover Phase I Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR Capsule 32 mg and Dilatrend Tablet 25 mg in Healthy Male Subjects

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.

Study Overview

• Status: Unknown
• Conditions: Essential Hypertension; Congestive Heart Failure; Chronic Stable Angina
• Intervention / Treatment: Drug: Dilatrend SR capsule 32mg; Drug: Dilatrend IR tablet 25mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • eok-dong 2(i)-ga Jung-gu
    • Daegu, eok-dong 2(i)-ga Jung-gu, Korea, Republic of, 700-721
      • KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dilatrend SR capsule 32mg	Drug: Dilatrend SR capsule 32mg; 1 capsule, oral, once daily, 7days; over the period I&II(crossover)
Active Comparator: Dilatrend IR tablet 25mg	Drug: Dilatrend IR tablet 25mg; 1 tablet, oral, once daily, 7days; over the period I&II(crossover)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCinf	AUCinf: Area Under the Concentration time curve with the last concentration extrapolated based on the elimination rate constant Kel	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	Css,max : Maximum drug concentration in plasma determined directly from individual concentration-time data	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	Css,min : Minimum drug concentration in plasma determined directly from individual concentration-time data	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	Tss,max : Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles	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	t½ : Observed terminal elimination half-life	0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
Number of participants with adverse events	Evaluated safety parameters included: physical examination, vital sign, laboratory test, ECG; adverse event monitoring	From 1day to 37 days

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): April 1, 2013
• Last Update Submitted That Met QC Criteria: March 29, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Carvedilol; Healthy male subjects; Dilatrend SR capsule; Dilatrend Tablet
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Hypertension; Chest Pain; Angina Pectoris; Heart Failure; Essential Hypertension; Angina, Stable; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Carvedilol
• Other Study ID Numbers: 125HPS12006