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NCT02283112 Clinical Trial

Validation of Drug Assays in Various Biological Matrices

Infection Clinical Trial

Official title:
Validation of Drug Assays in Various Biological Matrices

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02283112
Other study ID # RLUH 4520
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2014
Est. completion date December 2023

Study information
Verified date November 2023
Source University of Liverpool
Contact Helen Reynolds
Email her@liv.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > 18 years of age Exclusion Criteria: - Unable to give informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• antivirals, antimicrobials, oral contraceptive, erectile dysfunction agents

Locations
Country Name City State
United Kingdom Royal Liverpool & Broadgreen Univeristy Hospitals NHS Trust Liverpool

Sponsors (1)
Lead Sponsor Collaborator
Helen Reynolds

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To measure drug concentrations using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS) (accuracy and precision of assays that measure drug concentrations) Assay validation Follow up up to 5 years
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