NCT06519045

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

Pharmacokinetic Profiles of Codeine and Metabolites in Fingerprint Sweat, Oral Fluid, Blood and Urine Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Intelligent Bio Solutions Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: —

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

Type	Name	Description
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.

Timeline

• Start date: 2024-06-11
• Primary completion: 2024-08-31
• Completion: 2024-09-30
• First posted: 2024-07-25
• Last updated: 2024-07-25

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study