Status:
COMPLETED
Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
National Institute of Food and Drug Safety Evaluation, Korea
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
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 accord...
Eligibility Criteria
Inclusion
- 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
- Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
- Subject judged not eligible for study participation by investigator.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02286934
Start Date
September 1 2014
End Date
December 1 2014
Last Update
June 4 2015
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam, Gyounggi, South Korea