Cutoff Assessment for Codeine in Fingerprint Sweat Relative to Oral Fluid, Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults

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 30 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 within 30 days prior to dosing.
3. Healthy male and non-pregnant female subjects between ages 18 and 55, inclusive, at the time of dosing.
4. Body mass index (BMI) between 18.0 kg/m2 to 32.0 kg/m2, inclusive, and weigh at least 60 kg.
5. Judged by the Investigator and/or designee to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments along with oxygen saturation, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, ECG, etc.) can be repeated at the discretion of the Investigator and/or designee and judged to be not clinically significant for study participation. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation.
6. Subjects with glomerular filtration rate (GFR) of greater than or equal to 60.
7. Females of childbearing potential must be willing to practice an acceptable form of contraception, and have a negative serum pregnancy test at screening and a negative urine pregnancy test on admission to the treatment phase of the study.
8. Males must agree to practice an acceptable form of contraception.

Exclusion Criteria:

1. More than three digits absent from the hands due to congenital or accidental cause(s).
2. Reports receiving any investigational drug/product within 30 days prior to dosing.
3. 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.
4. Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the Investigator.
5. Presence of any clinically significant results from laboratory tests, vital signs assessments, as judged by the Investigator.
6. Demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
7. Reports a clinically significant illness during the 30 days prior to dosing (as determined by the Investigator).
8. Reports a history of allergic response(s) to opiates, naltrexone or related drugs.
9. Reports hypersensitivity to bisulfites.
10. Reports history of respiratory depression (e.g., sleep apnea).
11. Current severe hypotension (i.e., systolic blood pressure <90 mmHg).
12. Reports current presence of acute bronchial asthma/ upper airway obstruction.
13. If subject reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
14. Reports history/current condition of adrenal insufficiency.
15. Reports history/current condition of renal disease.
16. Reports a history of smoking within previous six months.
17. Report history/current condition of seizures, increased intracranial pressure, brain tumor, head injuries or impaired consciousness.
18. Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
19. Reports difficulty fasting or consuming standardized meals.
20. Demonstrates a positive pregnancy screen (females only).
21. If, in the opinion of the Investigator, the subject is not suitable for the study.