Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

Study Overview
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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

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Carvedilol
* Other: Isoproterenol Sensitivity Test


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carvedilol<br>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. | Drug: Carvedilol<br>* 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<br>Other: Isoproterenol Sensitivity Test<br>* Day 0, 1, 8 : Isoproterenol Sensitivity Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carvedilol, CYP2D6, Isoproterenol Sensitivity Test