An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers

An Bioequivalence Study of Loxoprofen Sodium Patches in Chinese Healthy Volunteers

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

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis; Muscle Pain; Swelling Muscle
• Intervention / Treatment: Drug: Loxoprofen Sodium Patches(reference product); Drug: Loxoprofen Sodium Patches(test product )

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cheng Yao; Phone Number: +86 02569760330; Email: yaocheng@frontierbiotech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: Loxoprofen Sodium Patches(reference product); Single dose of one patch in each period; Apply for 24 hours each time; Other Names: Loxonin®; Drug: Loxoprofen Sodium Patches(test product ); Single dose of one patch in each period; Apply for 24 hours each time; Other Names: FB3002
Other: 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	Drug: Loxoprofen Sodium Patches(reference product); Single dose of one patch in each period; Apply for 24 hours each time; Other Names: Loxonin®; Drug: Loxoprofen Sodium Patches(test product ); Single dose of one patch in each period; Apply for 24 hours each time; Other Names: FB3002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	All of the adverse events will be reported	0-14 days
Tmax of loxoprofen and its trans-OH	Time to reach maximum plasma concentration	0-72 hours
t1/2 of loxoprofen and its trans-OH	Apparent terminal elimination half-life	0-72 hours
λz	Apparent terminal elimination rate constant	0-72 hours
AUC_%Extrap	Percentage of AUCINF(_obs, _pred) due to extrapolation from Tlast to infinity	0-72 hours
Irritation score	A combined irritation score should be calculated by adding the "dermal response" score and the numeric equivalent for "other effects" letter score.	0-14 days

Collaborators and Investigators

• Sponsor: Frontier Biotechnologies Inc.
• Investigators: Study Director: Cheng Yao, Frontier Biotechnologies Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Loxoprofen
• Other Study ID Numbers: JY-BE-LSLF-2024-042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No