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

Unknown statusPhase 1NCT01819870
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

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
Conditions
Interventions
  • Drug: Dilatrend SR capsule 32mg
  • Drug: Dilatrend IR tablet 25mg
Sponsor
Chong Kun Dang Pharmaceutical
Start date
2013-04
Primary completion
2013-05
Sex
Male
Age range
from 20 Years to 35 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01819870