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."
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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 be in good health as documented by the medical history, and vital sign assessments.
Exclusion Criteria:
1. Unwilling or unable to provide informed consent.
2. More than three digits absent from the hands due to congenital or accidental cause(s).
3. Reports receiving any investigational drug within 30 days prior to dosing.
4. Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
5. Reports any personal history of substance abuse (including drug/alcohol abuse or addiction) or mental illness (e.g. major depression) within one year prior to screening visit.
6. Is pregnant (females only).
7. Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
8. Reports history of respiratory depression (e.g., sleep apnea).
9. Reports history of reaction to codeine (e.g., nausea, allergy).
10. Current severe hypotension (i.e., systolic blood pressure \<90 mmHg).
11. Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
12. Reports current presence of acute bronchial asthma/ upper airway obstruction.
13. Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
14. Reports history or current condition of adrenal insufficiency.
15. Reports history or current condition of renal disease.
16. If, in the opinion of the Investigator, the subject is not suitable for the study.
Primary outcome measure(s)
Sensitivity — 24 hrs Sensitivity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
Specificity — 24 hrs Specificity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
Accuracy — 24 hrs Accuracy of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine
Trial sites (1)
Facility
City
Region
Status
CenExel Clinical Research
Marlton
New Jersey
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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