Status:
NOT_YET_RECRUITING
An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers
Lead Sponsor:
Frontier Biotechnologies Inc.
Conditions:
Osteoarthritis
Muscle Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 bioa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06510413
Start Date
July 1 2024
End Date
August 1 2024
Last Update
July 19 2024
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