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

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01819870
• Other study ID #: 125HPS12006
• Status: Not yet recruiting
• Phase: Phase 1
• First received: March 20, 2013
• Last updated: March 29, 2013
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: January 2013
• Source: Chong Kun Dang Pharmaceutical
• Contact: Young-Ran Yoon
• Phone: 053-420-4950
• Email: yry[@]knu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Stable Angina
• Congestive Heart Failure
• Essential Hypertension
• Heart Failure
• Hypertension

Intervention

Drug:
• Dilatrend SR capsule 32mg
1 capsule, oral, once daily, 7days over the period I&II(crossover)
• Dilatrend IR tablet 25mg
1 tablet, oral, once daily, 7days over the period I&II(crossover)

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital Clinical Trial Center	Daegu	eok-dong 2(i)-ga Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	Yes