Clinical trial NCT01819870: Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR Capsule 32mg and Dilatrend Tablet 25mg
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Essential Hypertension
Chronic Stable Angina
Congestive Heart Failure
Keywords: Carvedilol
Dilatrend SR capsule
Dilatrend Tablet
Pharmacokinetics
Healthy male subjects
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCtau
timeFrame: 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:
measure: In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg AUCinf
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
measure: In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,max
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
measure: In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Css,min
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
measure: In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg Tss,max
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
measure: In the steady state Dilatrend SR Capsule 32mg and Dilatrend tablet 25mg t½
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48hr post-dose (on last day of each period)
measure: Number of participants with adverse events
timeFrame: From 1day to 37 days
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital Clinical Trial Center
state: eok-dong 2(i)-ga Jung-gu
Study officials:
affiliation: Kyungpook National University Hospital Clinical Trial Center
name: Young-Ran Yoon
role: PRINCIPAL_INVESTIGATOR
References: