Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

Seoul National University Hospital24 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CarvedilolDRUG

* 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 TestOTHER

Day 0, 1, 8 : Isoproterenol Sensitivity Test

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

Outcomes

Primary Outcomes

AUC (area under the plasma concentration-time curve) of carvedilol

Time frame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose

Cmax (Maximum plasma concentration) of carvedilol

Time frame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose

Data from ClinicalTrials.gov

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