Clinical trial NCT06510413: An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers
Official title: An Bioequivalence Study of Loxoprofen Sodium Patches in Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Osteoarthritis
Muscle Pain
Swelling Muscle
Lead sponsor: Frontier Biotechnologies Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cmax of loxoprofen and its trans-OH
timeFrame: 0-72 hours
measure: AUC0-T of loxoprofen and its trans-OH
timeFrame: 0-72 hours
measure: AUC0-∞ of loxoprofen and its trans-OH
timeFrame: 0-72 hours
Secondary outcomes:
measure: Adverse Events
timeFrame: 0-14 days
measure: Tmax of loxoprofen and its trans-OH
timeFrame: 0-72 hours
measure: t1/2 of loxoprofen and its trans-OH
timeFrame: 0-72 hours
measure: λz
timeFrame: 0-72 hours
measure: AUC_%Extrap
timeFrame: 0-72 hours
measure: Irritation score
timeFrame: 0-14 days
Other outcomes:
Locations:
Study officials:
affiliation: Frontier Biotechnologies Inc.
name: Cheng Yao
role: STUDY_DIRECTOR
References: