Study to Compare the Pharmacokinetic Characteristics and Safety of Dilatrend SR capsule 32 mg and Dilatrend® tablet 25 mg
- Conditions
- Not Applicable
- Registration Number
- KCT0000787
- Lead Sponsor
- Chong Kun Dang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 48
1)Between 20 aged and 35aged in healthy male
2)Body Weight more than 50kg, and within 20% of ideal body weight(IBW).
IBW(kg) = {height(cm)-100}*0.9
3)Have not any congenital or chronic disease and medical symptoms.
4)Suitable results of inspections(laboratory test, ECG, etc) within 21 days before IP administration.
5)Agreement with written informed consent
-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
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCtau of Carvedilol
- Secondary Outcome Measures
Name Time Method AUCinf, Css,max, Css,min, Tss,max, t1/2 of Carvedilol