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A Genotype Stratification Study for Pharmacokinetics and Pharmacodynamics of Amitriptyline in Healthy Male Subjects

Depression Clinical Trial

Official title:
A Single Dose, Double-blind, Genotype-based Stratification Study to Explore the Pharmacokinetics and Pharmacodynamics of Amitriptyline According to CYP2D6 and CYP2C19 Polymorphisms in Healthy Korean Male Adult Subjects

Clinical Trial Summary

A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline, 25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma concentrations of amitriptyline, nortriptyline, and their metabolites. Various pharmacodynamic markers related to the adverse event of amitriptyline will be measured serially during the study.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02519400
Study type Interventional
Source Asan Medical Center
Contact Shi Hyang Lee, MS
Phone 82-2-3010-4622
Email shlee@acp.kr
Status Not yet recruiting
Phase Phase 1
Start date August 2015
View Details
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