This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Single dose of one patch in each period; Apply for 24 hours each time
Single dose of one patch in each period; Apply for 24 hours each time
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
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
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
Adverse Events
All of the adverse events will be reported
Time frame: 0-14 days
Tmax of loxoprofen and its trans-OH
Time to reach maximum plasma concentration
Time frame: 0-72 hours
t1/2 of loxoprofen and its trans-OH
Apparent terminal elimination half-life
Time frame: 0-72 hours
λz
Apparent terminal elimination rate constant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 0-72 hours
AUC_%Extrap
Percentage of AUCINF(\_obs, \_pred) due to extrapolation from Tlast to infinity
Time frame: 0-72 hours
Irritation score
A combined irritation score should be calculated by adding the "dermal response" score and the numeric equivalent for "other effects" letter score.
Time frame: 0-14 days