Health TrialsbyHealthPanel

An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers

ConditionsOsteoarthritisMuscle PainSwelling Muscle
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Loxoprofen Sodium Patches(reference product)

    Drug

    Single dose of one patch in each period; Apply for 24 hours each time

  • Loxoprofen Sodium Patches(test product )

    Drug

    Single dose of one patch in each period; Apply for 24 hours each time

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Loxoprofen Sodium Patches (Sequence TR)Other 2 interventions
Group B: Loxoprofen Sodium Patches (Sequence RT)Other 2 interventions

Trial outcomes

Primary outcomes

1

Cmax of loxoprofen and its trans-OH

Maximum plasma concentration. Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25.

Time frame
0-72 hours
2

AUC0-T of loxoprofen and its trans-OH

Area under the plasma concentration curve from time 0 to the last measured (AUC0-t). Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25.

Time frame
0-72 hours
3

AUC0-∞ of loxoprofen and its trans-OH

Area under the plasma concentration curve from time 0 to ∞ (AUC0-∞). Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25.

Time frame
0-72 hours

Secondary outcomes

1

Adverse Events

All of the adverse events will be reported

Time frame
0-14 days
2

Tmax of loxoprofen and its trans-OH

Time to reach maximum plasma concentration

Time frame
0-72 hours
3

t1/2 of loxoprofen and its trans-OH

Apparent terminal elimination half-life

Time frame
0-72 hours
4

λz

Apparent terminal elimination rate constant

Time frame
0-72 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Frontier Biotechnologies Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: