An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers

NCT06510413 | Not Yet Recruiting Phase 1

• 1 other identifier: JY-BE-LSLF-2024-042
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.

Conditions

Osteoarthritis; Muscle Pain; Swelling Muscle

Outcome Measures

Primary Outcomes (3)

• Cmax of loxoprofen and its trans-OH

  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.

  0-72 hours

• AUC0-T of loxoprofen and its trans-OH

  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.

  0-72 hours

• AUC0-∞ of loxoprofen and its trans-OH

  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.

  0-72 hours

Secondary Outcomes (6)

• Adverse Events

  0-14 days

• Tmax of loxoprofen and its trans-OH

  0-72 hours

• t1/2 of loxoprofen and its trans-OH

  0-72 hours

• λz

  0-72 hours

• AUC_%Extrap

  0-72 hours

Study Arms (2)

Loxoprofen Sodium Patches (Sequence TR)

OTHER

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.

Drug: Loxoprofen Sodium Patches(reference product); Drug: Loxoprofen Sodium Patches(test product )

Loxoprofen Sodium Patches (Sequence RT)

OTHER

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

Drug: Loxoprofen Sodium Patches(reference product); Drug: Loxoprofen Sodium Patches(test product )

Interventions

Loxoprofen Sodium Patches(reference product) DRUG

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

Also known as: Loxonin®

Loxoprofen Sodium Patches (Sequence RT); Loxoprofen Sodium Patches (Sequence TR)

Loxoprofen Sodium Patches(test product ) DRUG

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

Also known as: FB3002

Loxoprofen Sodium Patches (Sequence RT); Loxoprofen Sodium Patches (Sequence TR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19.0 and 28.0 kg/m2, inclusive .
• The subjects are well communicated and are able to comply with the requirements of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

MeSH Terms

Conditions

Osteoarthritis; Myalgia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cheng Yao

  Frontier Biotechnologies Inc.

  STUDY DIRECTOR

Central Study Contacts

Cheng Yao

CONTACT

+86 02569760330; yaocheng@frontierbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: July 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07