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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

NCT ID: NCT01340248

Last Updated: 2011-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Stable Angina

Keywords

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food effect pharmacokinetics healthy male volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Dilatrend 64mg capsule

Intervention Type DRUG

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

Interventions

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Dilatrend 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Cho, Jung Ah/CRA

Locations

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Kyungpook national university

Daegu, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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125HPS11F

Identifier Type: -

Identifier Source: org_study_id