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

• . 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.
• . 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.
• . Healthy male and non-pregnant female subjects between ages 18 and 55, inclusive, at the time of dosing.
• . Body mass index (BMI) between 18.0 kg/m2 to 32.0 kg/m2, inclusive, and weigh at least 60 kg.
• . 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.