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

Chong Kun Dang Pharmaceutical1 site in 1 country24 target enrollmentJuly 2011

ConditionsChronic Stable Angina

InterventionsDilatrend 64mg capsule

DrugsDilatrend 64mg capsule

Overview

Phase: Phase 1
Intervention: Dilatrend 64mg capsule
Conditions: Chronic Stable Angina
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 24
Locations: 1
Primary Endpoint: evaluation of pharmacokinetics
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

August 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Eligibility Criteria

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

Arms & Interventions

Dilatrend 64mg capsule

\* Randomized, open-label, single dose, two-period, two-way, crossover study 1. group : Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet 2. group : Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting

Intervention: Dilatrend 64mg capsule