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

Status and phase: Completed; Phase 1

Conditions: Chronic Stable Angina

Treatments: Drug: Dilatrend 64mg capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340248

125HPS11F

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

Dilatrend 64mg capsule

Experimental group

Description:

\* 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

Treatment:

Drug: Dilatrend 64mg capsule