An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFrontier Biotechnologies Inc.
About this trial
This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.
Eligibility criteria
Qualifiers
Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19.0 and 28.0 kg/m2, inclusive .
Informed consent: signed written informed consent before inclusion in the study.
The subjects are well communicated and are able to comply with the requirements of the study
Disqualifiers
Participated in other drug intervention studies within 90 days
Allergic to this product and excipients, or have a history of food, drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.)
Aspirin asthma
Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial.
Trial design
Treatments tested in this trial
- Loxoprofen Sodium Patches(reference product)
- Loxoprofen Sodium Patches(test product )
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov