Intelligent Bio Solutions Inc.
Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System
95 healthy adults, male and non-pregnant female subjects. Each subject receives two doses of 60mg codeine sulfate in tablet form, the second dose four hours after the first. The first twenty subjects enrolled provide fingerprint sweat specimens for Sample Collection Cartridge stability evaluation. Each of the remaining 75 subjects provides fingerprint sweat specimens for evaluation of interference effects. These 75 subjects handle two interferents prior to providing fingerprint sweat specimens, both before and after receiving the codeine sulfate dose.
Inclusion Criteria: 1. Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English. 2. Completed the screening process within 60 days prior to dosing. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures provided all the required screening procedures have been performed…
Device will be stored prior to and following sample collection.
Interferent will be applied to subjects' fingers prior to measurement of drug in fingerprint sweat.
Arctuva estimate
Actual pay is set by the research site.
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