User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison
Intelligent Bio Solutions Inc.
Summary
Prospective, multi-site, open-label, single- or double-dose, randomized, multi-site performance evaluation of accuracy of the Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."
Description
This will be a study under non-fasting conditions. The total number of healthy adult "operator" subjects (male and non-pregnant females) required for enrollment in this study protocol is nine (9). The total number of healthy adult "donor" subjects (male and non-pregnant females) required for enrollment in this study protocol is 135. These subjects will be distributed across three sites with the recruiting goal of three (3) operators and 45 subjects per site. Subjects will be recruited to participate as either "operator" or "donor." The total duration of the study, from check-in through the en…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1\. Able to provide informed consent 2. Completed the screening process within 30 days prior to dosing. 3. Healthy male and non-pregnant female subjects at the time of dosing. 4. Body mass index (BMI) from 18.0 kg/m2 to 32.0 kg/m2, inclusive 5. Weigh at least 60 kg. 5. Females of childbearing potential must be willing to practice an acceptable form of contraception, and have a negative urine pregnancy test on admission to the treatment phase of the study. 6\. Males must agree to practice an acceptable form of contraception 7. Judged by the Investigator and/or designee to…
Interventions
- DeviceDiagnostic Test
Measurement of codeine in human fingerprint sweat
Location
- CenExel Clinical ResearchMarlton, New Jersey