An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers

Launched by FRONTIER BIOTECHNOLOGIES INC. · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of pain relief patch called Loxoprofen Sodium, which is being tested to see how well it works compared to other similar treatments. It is aimed at healthy volunteers, and the results will help determine if this patch is safe and effective for managing conditions like osteoarthritis, muscle pain, and swelling. The study is not yet recruiting participants, but when it does, it will be looking for men and women aged between 18 and 65 who meet specific health criteria, such as having a healthy weight and being able to follow study instructions.

If you join the study, you will need to sign a consent form, which means you agree to participate and understand what the study involves. Participants will be closely monitored throughout the trial, and they will not be allowed to use certain medications or substances, like tobacco and caffeine, during the study period. It’s important to note that if you have certain medical conditions, allergies, or have participated in other drug studies recently, you may not be eligible to join. Overall, this trial aims to gather valuable information that could improve pain relief options in the future.

Gender

ALL

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