Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

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

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol

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Detailed Description

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This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carvedilol

* Day 1 to 3 : Carvedilol 12.5 mg qd
* Day 4 to 8 : Carvedilol 25 mg qd
* Day 9 to 11 : Carvedilol 12.5 mg qd

Isoproterenol Sensitivity Test

* Day 0, 1.5h post-dose Injection of isoproterenol 4 times (0.25, 0.5, 1, 2 ug/mL), time interval of 10 minutes.
* Day 1, 8, 1.5h post-dose Injection of isoproterenol 4 times (5, 10, 20, 40 ug/mL), time interval of 10 minutes.

Measure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol.

Group Type EXPERIMENTAL

Carvedilol

Intervention Type DRUG

* Day 1 to 3 : Carvedilol 12.5 mg qd
* Day 4 to 8 : Carvedilol 25 mg qd
* Day 9 to 11 : Carvedilol 12.5 mg qd

Isoproterenol Sensitivity Test

Intervention Type OTHER

Day 0, 1, 8 : Isoproterenol Sensitivity Test

Interventions

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Carvedilol

* Day 1 to 3 : Carvedilol 12.5 mg qd
* Day 4 to 8 : Carvedilol 25 mg qd
* Day 9 to 11 : Carvedilol 12.5 mg qd

Intervention Type DRUG

Isoproterenol Sensitivity Test

Day 0, 1, 8 : Isoproterenol Sensitivity Test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy Subjects aged 20 - 45 years
* A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).
* Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion Criteria

* Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
* Subject judged not eligible for study participation by investigator.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes