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A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers

CompletedPhase 1NCT01340248
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)

A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of Dilatrend SR 64mg capsule after oral administration in healthy male volunteers.

Study details

Official title
A Randomized, Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Dilatrend SR 64mg Capsule After Oral Administration in Healthy Male Volunteers
Interventions
  • Drug: Dilatrend 64mg capsule
Sponsor
Chong Kun Dang Pharmaceutical
Start date
2011-07
Primary completion
2011-08
Sex
Male
Age range
from 20 Years to 50 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 50 aged in healthy adults * Weight more than 55kg, IBW 20% within the range * Agreement with written informed consent Exclusion Criteria: * Subject has hypersensitivity reaction or clinically significant history about investigational drug * Clinically significant cardiovascular system, respiratory system, liver, renal, endocrine system, gastrointestinal system, central nervous system, blood tumor, mental disease, skin disease and so on * Inadequate result of laboratory test * AST(SGOT) or ALT(SGPT) \> 1.5 x upper limit of normal range * Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 210 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette \> 10 cigarettes per day) * Creatinine clearance \< 80ml/min * Subject with known for history(such as gastrointestinal disease or operation) with affect the absorption of drug * Subject takes an abnormal meal which affect the ADME of drug * Previously participated in other trial within 90 days * Previously make whole blood donation within 60 days or component blood donation within 30 days * Subject with positive reaction for reason of laboratory test result * 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/NCT01340248