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.
Study Type
OBSERVATIONAL
Enrollment
40
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.
Cliantha Research
Mississauga, Ontario, Canada
Maximum concentration (Cmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine
Peak concentration in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of specimens
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Time to reach maximum concentration (Tmax) of codeine and codeine-6-glucuronide in fingerprint sweat, oral fluid, plasma, and urine
Time after drug administration at which peak plasma concentration occurs in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of specimens
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Area under the curve (AUC) of codeine in fingerprint sweat, oral fluid, plasma, and urine
Efficiency of physiological processes that characterize the drug elimination in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Terminal half-life (T1/2) of codeine in fingerprint sweat, oral fluid, plasma, and urine
The period of time that it takes for the concentration of codeine and codeine-6-glucuronide to decrease by 50% in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
Clearance of codeine in fingerprint sweat, oral fluid, plasma, and urine
Amount of codeine eliminated per unit of time/ drug concentration in each of fingerprint sweat, oral fluid, plasma, and urine, as calculated from LC-MS/MS analysis of codeine and codeine-6-glucuronide in specimens
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose
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Sensitivity of fingerprint sweat screening system for codeine
Comparison of results of fingerprint sweat screening system to LC-MS/MS analysis of fingerprint sweat specimens for codeine
Time frame: From -1 hr to 24 hrs relative to codeine sulfate dose