An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers

NCT ID: NCT06510413

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2024-08-31

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.

Conditions

Osteoarthritis; Muscle Pain; Swelling Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Loxoprofen Sodium Patches (Sequence TR)

Dosage form: patch

Dosage: 100 mg/ patch

Frequency and duration: single dose

Subjects receive the test product (T) in the first period, then the reference product (R) in the second period.

Group Type: OTHER

Loxoprofen Sodium Patches(reference product)

Intervention Type: DRUG

Single dose of one patch in each period; Apply for 24 hours each time

Loxoprofen Sodium Patches(test product )

Intervention Type: DRUG

Single dose of one patch in each period; Apply for 24 hours each time

Loxoprofen Sodium Patches (Sequence RT)

Dosage form: patch

Dosage: 100 mg/ patch

Frequency and duration: single dose

Subjects receive the reference product (R) in the first period, then the test product (T) in the second period

Group Type: OTHER

Loxoprofen Sodium Patches(reference product)

Intervention Type: DRUG

Single dose of one patch in each period; Apply for 24 hours each time

Loxoprofen Sodium Patches(test product )

Intervention Type: DRUG

Single dose of one patch in each period; Apply for 24 hours each time

Interventions

Loxoprofen Sodium Patches(reference product)

Single dose of one patch in each period; Apply for 24 hours each time

Intervention Type: DRUG

Loxoprofen Sodium Patches(test product )

Single dose of one patch in each period; Apply for 24 hours each time

Intervention Type: DRUG

Other Intervention Names

Loxonin®; FB3002

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Frontier Biotechnologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheng Yao

Role: STUDY_DIRECTOR

Frontier Biotechnologies Inc.

Central Contacts

Cheng Yao

Role: CONTACT

yaocheng@frontierbiotech.com

+86 02569760330

Other Identifiers

JY-BE-LSLF-2024-042

Identifier Type: -

Identifier Source: org_study_id