Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02286934

Enrollment

Registered

2014-11-10

Start date

2014-09-30

Completion date

2014-12-31

Last updated

2015-06-04

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

Conditions

Healthy

Keywords

Carvedilol, CYP2D6, Isoproterenol Sensitivity Test

Brief summary

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

Detailed description

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

Interventions

DRUGCarvedilol

* 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

OTHERIsoproterenol Sensitivity Test

Day 0, 1, 8 : Isoproterenol Sensitivity Test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUC (area under the plasma concentration-time curve) of carvedilol	predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
Cmax (Maximum plasma concentration) of carvedilol	predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026