Muscle Pain, Osteoarthritis, Swelling Muscle
Conditions
Brief 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.
Interventions
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
Sponsors
Frontier Biotechnologies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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. * A history of cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, immune system, nervous/psychiatric system, blood and lymphatic system, and skeletal musculoskeletal system that investigator have determined to be abnormal and clinically significant * Postural hypotension, needle fainting or blood fainting history or venipuncture intolerance * Any drug that inhibits or induces liver metabolism has been used in the 30 days prior to screening. Inducers: barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole; Inhibitors: SSRI antidepressants, cimetidine, Diltiazem, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines * Blood donation or significant blood loss (\>400 mL, except for female menstrual period) in the 3 months prior to screening, blood transfusion or use of blood products, or have a blood donation plan during/within 3 months after the study * Smoked more than 5 cigarettes per day in the 3 months prior to screening, or unwilling to prohibit the use of any tobacco products during the trial period * History of alcohol abuse within 6 months * Subjects who consumed excessive amounts of tea, coffee or caffeinated beverages within 3 months, or who did not agree to the prohibition of tea, coffee or caffeinated beverages in the study * Subjects who have special requirements for diet and cannot comply with a unified diet * History of drug abuse within 1 year * Subjects who have unprotected sex in 2 weeks, or planned to have a child during the study period, planned to donate sperm and eggs, or are unwilling to use one or more non-drug contraceptive methods during the study, or are unwilling to use contraception within 3 months after the study * Pregnant or nursing women * Positive skin scratch test positive * Clinically significant vital signs laboratory, physical examination, or 12-lead electrocardiogram abnormalities as judged by the investigator * Other situations that the investigator determines are not suitable for participating in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of loxoprofen and its trans-OH | 0-72 hours | 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. |
| AUC0-T of loxoprofen and its trans-OH | 0-72 hours | 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. |
| AUC0-∞ of loxoprofen and its trans-OH | 0-72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| λz | 0-72 hours | Apparent terminal elimination rate constant |
| Adverse Events | 0-14 days | All of the adverse events will be reported |
| Irritation score | 0-14 days | A combined irritation score should be calculated by adding the dermal response score and the numeric equivalent for other effects letter score. |
| AUC_%Extrap | 0-72 hours | Percentage of AUCINF(\_obs, \_pred) due to extrapolation from Tlast to infinity |
| Tmax of loxoprofen and its trans-OH | 0-72 hours | Time to reach maximum plasma concentration |
| t1/2 of loxoprofen and its trans-OH | 0-72 hours | Apparent terminal elimination half-life |
Contacts
Primary ContactCheng Yao
Outcome results
None listed