Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cliantha Research | OTHER |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Dosed with 3x60mg codeine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intelligent Fingerprinting Drug Screening System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From -1 hr to 24 hrs relative to codeine sulfate dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects will be selected from non-institutionalized subjects consisting of members of the community at large.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philip Mathew, MD | Cliantha Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliantha Research | Mississauga | Ontario | L4W1N2 | Canada |
Not provided
Not provided
Not provided
Not provided
Fingerprint sweat, oral fluid, whole blood, and urine specimens will be collected. No DNA analysis will take place.
|
| From -1 hr to 24 hrs relative to codeine sulfate dose |