Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Carvedilol (Drug); Isoproterenol Sensitivity Test (Other)
Phase: Phase 1
Status: Completed
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s): Jae-Yong Chung, MD, PhD, Principal Investigator, Affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Kore
Summary
A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on
Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol
Clinical Details
Official title: A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC (area under the plasma concentration-time curve) of carvedilolCmax (Maximum plasma concentration) 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
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Seoul National University Bundang Hospital, Seongnam, Gyounggi, Korea, Republic of
Additional Information
Starting date: September 2014
Last updated: June 2, 2015
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