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PK of Codeine and Metabolites in Human Fingerprint Sweat, Oral Fluid, Blood and Urine

NCT06519045 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-07-25

No results posted yet for this study

Summary

This study will compare positive and negative test results obtained from fingerprint sweat using the Intelligent Fingerprinting Drug Screening Cartridge, versus opiates in sweat collected via the Fingerprint Collection Kit for Laboratory Analysis, versus blood, oral fluid and urine sample concentrations of opiates identified within codeine phosphate dosed healthy males and non-pregnant females.

Conditions

  • Pharmacokinetics

Interventions

DEVICE

Intelligent Fingerprinting Drug Screening System

The Intelligent Fingerprinting Drug Screening System utilizes a single-use, rapid, non-invasive fingerprint sweat drug screening test intended for use with the Intelligent Fingerprinting DSR-Plus fluorescence reader. The Intelligent FingerprintingTM Fingerprint Collection Kit for Laboratory Analysis (i.e. confirmation test) provides a quantitative analytical result via laboratory-based liquid chromatography/tandem mass spectrometry (LC-MS/MS). It is used to collect and measure drug mass in the full set of 10 fingerprints.

Sponsors & Collaborators

  • Cliantha Research

    collaborator OTHER

  • Intelligent Bio Solutions Inc.

    lead INDUSTRY

Principal Investigators

  • Philip Mathew, MD · Cliantha Research

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2024-08-31
Completion
2024-09-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06519045 on ClinicalTrials.gov