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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 carvedilol

Cmax (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

Page last updated: August 20, 2015

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