clinical trial · NCT05422131
Clozapine Therapy Sample Collection - Method Comparison Study
Saladax Biomedical, Inc.·—·completed·n = 153
Patients Prescribed ClozapineMyCare Insite Clozapine Test
brief summary
The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.
started
Nov 12, 2022
primary completion
Jan 25, 2023
completion
May 16, 2023
last updated
May 18, 2023
official title
Collection of Capillary Fingerstick Blood, Venous Serum, and Venous K2EDTA Blood Samples From Subjects Receiving Clozapine Therapy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol