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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01340248

Enrollment

Registered

2011-04-22

Start date

2011-07-31

Completion date

2011-08-31

Last updated

2011-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stable Angina

Keywords

food effect, pharmacokinetics, healthy male volunteers

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.

Interventions

DRUGDilatrend 64mg capsule

1. Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet 2. Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
evaluation of pharmacokinetics	pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48h	The effect of food on PK after high fat diet and fasting Blood sampling over a 72 hour period post dose in all dosing sessions

Secondary

Measure	Time frame	Description
evaluation of safety	from screenig to post-study visit	* adverse event monitoring * physical examination, vital sign, ECOG, laboratory test

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026