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

NCT07755267 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2026-08-10

No results posted yet for this study

Summary

This is a prospective, observational, open-label, single-site, in-clinic study with two 20-subject cohorts. Each subject receives two (2) doses of 60mg codeine phosphate in tablet form, the second dose four (4) hours after the first.

The primary objective of this study is to compare data from a fingerprint sweat opiate fluorescence immunoassay screening method to oral fluid opiate screening in subjects dosed with codeine phosphate. Fluorescence measurement data from the fingerprint sweat screening method will be analyzed post hoc to select the fingerprint sweat codeine cutoff best aligned with the oral fluid cutoff.

The secondary objective is to compare LC-MS/MS data from fingerprint sweat specimens and oral fluid in order to select the fingerprint sweat codeine cutoff best aligned with codeine in oral fluid.

Conditions

  • Healthy Adult

Interventions

DEVICE

Determination of codeine phosphate

Measurement of codeine phosphate in oral fluid and fingerprint sweat of dosed subjects

Sponsors & Collaborators

  • Cliantha Research

    collaborator OTHER

  • Intelligent Bio Solutions Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2026-02-06
Completion
2026-02-06
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755267 on ClinicalTrials.gov