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

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01819870

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension Chronic Stable Angina Congestive Heart Failure	Drug: Dilatrend SR capsule 32mg Drug: Dilatrend IR tablet 25mg	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

May 1, 2013

Anticipated Study Completion Date :

Aug 1, 2013

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau [0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)]
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

Secondary Outcome Measures

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)]
AUCinf: Area Under the Concentration time curve with the last concentration extrapolated based on the elimination rate constant Kel
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)]
Css,max : Maximum drug concentration in plasma determined directly from individual concentration-time data
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)]
Css,min : Minimum drug concentration in plasma determined directly from individual concentration-time data
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)]
Tss,max : Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles
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)]
t½ : Observed terminal elimination half-life
Number of participants with adverse events [From 1day to 37 days]
Evaluated safety parameters included: physical examination, vital sign, laboratory test, ECG adverse event monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.