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Not Yet RecruitingNCT06510413

An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers

An Bioequivalence Study of Loxoprofen Sodium Patches in Chinese Healthy Volunteers

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Frontier Biotechnologies Inc. · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.

Detailed description

The objectives of this study are to evaluate the difference of absorption degree and absorption rate of two kinds of patches( FB3002 vs. Loxonin®) in Chinese healthy population, and to assess the bioavailability of these two patches.

Conditions

Interventions

TypeNameDescription
DRUGLoxoprofen Sodium Patches(reference product)Single dose of one patch in each period; Apply for 24 hours each time
DRUGLoxoprofen Sodium Patches(test product )Single dose of one patch in each period; Apply for 24 hours each time

Timeline

Start date
2024-07-01
Primary completion
2024-08-01
Completion
2024-08-01
First posted
2024-07-19
Last updated
2024-07-19

Source: ClinicalTrials.gov record NCT06510413. Inclusion in this directory is not an endorsement.

An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers (NCT06510413) · Clinical Trials Directory