Trials / Unknown

UnknownNCT02519400

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

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

Status: Unknown
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (estimated)

Sponsor: Asan Medical Center · Academic / Other
Sex: Male
Age: 19 Years – 45 Years
Healthy volunteers: Accepted

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.

Conditions

Depression

Interventions

Type	Name	Description
DRUG	Amitriptyline	Single oral dosing

Timeline

Start date: 2015-08-01
Primary completion: 2015-10-01
First posted: 2015-08-10
Last updated: 2015-08-11

Source: ClinicalTrials.gov record NCT02519400. Inclusion in this directory is not an endorsement.