OsteoarthritisPhase 1NCT06510413
An Bioequivalence Study of Loxoprofen Sodium Patches in Healthy Volunteers
A Phase 1 study testing Loxoprofen Sodium Patches(reference product) and Loxoprofen Sodium Patches(test product ) in people with Osteoarthritis and Muscle Pain, run by Frontier Biotechnologies Inc..
Trial summary
This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Muscle Pain, Swelling Muscle
- What is being tested?
- Loxoprofen Sodium Patches(reference product) and Loxoprofen Sodium Patches(test product )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Loxoprofen Sodium Patches(reference product), Loxoprofen Sodium Patches(test product )
- Medical subject headings
- Osteoarthritis, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loxoprofen Sodium Patches(reference product)Drug
Also called Loxonin®
Single dose of one patch in each period; Apply for 24 hours each time
Loxoprofen Sodium Patches(test product )Drug
Also called FB3002
Single dose of one patch in each period; Apply for 24 hours each time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Loxoprofen Sodium Patches(reference product); Drug: Loxoprofen Sodium Patches(test product ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0-72 hours
Secondary outcomes (6)
Adverse Events
All of the adverse events will be reported
Measured: 0-14 days
Tmax of loxoprofen and its trans-OH
Time to reach maximum plasma concentration
Measured: 0-72 hours
t1/2 of loxoprofen and its trans-OH
Apparent terminal elimination half-life
Measured: 0-72 hours
λz
Apparent terminal elimination rate constant
Measured: 0-72 hours
AUC_%Extrap
Percentage of AUCINF(_obs, _pred) due to extrapolation from Tlast to infinity
Measured: 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.
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Yao, Study director, Frontier Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510413
- Sponsor's protocol ID
- JY-BE-LSLF-2024-042
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Bioequivalence Study of Loxoprofen Sodium Patches in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06510413
- Acronym / sponsor ID
- JY-BE-LSLF-2024-042
- Conditions
- Osteoarthritis, Muscle Pain, Swelling Muscle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loxoprofen Sodium Patches (Sequence TR) | Other | Drug: Loxoprofen Sodium Patches(reference product), Drug: Loxoprofen Sodium Patches(test product )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. |
| Loxoprofen Sodium Patches (Sequence RT) | Other | Drug: Loxoprofen Sodium Patches(reference product), Drug: Loxoprofen Sodium Patches(test product )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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loxoprofen Sodium Patches(reference product)Also: Loxonin®Single dose of one patch in each period; Apply for 24 hours each time | Drug | Loxoprofen Sodium Patches (Sequence RT), Loxoprofen Sodium Patches (Sequence TR) |
| Loxoprofen Sodium Patches(test product )Also: FB3002Single dose of one patch in each period; Apply for 24 hours each time | Drug | Loxoprofen Sodium Patches (Sequence RT), Loxoprofen Sodium Patches (Sequence TR) |
Primary outcome
Cmax of loxoprofen and its trans-OH
Time frame: 0-72 hours
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.
AUC0-T of loxoprofen and its trans-OH
Time frame: 0-72 hours
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.
AUC0-∞ of loxoprofen and its trans-OH
Time frame: 0-72 hours
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.
6 secondary outcomes
Adverse Events
Time frame: 0-14 days
Tmax of loxoprofen and its trans-OH
Time frame: 0-72 hours
t1/2 of loxoprofen and its trans-OH
Time frame: 0-72 hours
λz
Time frame: 0-72 hours
AUC_%Extrap
Time frame: 0-72 hours
Irritation score
Time frame: 0-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng Yao study director
Frontier Biotechnologies Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Loxoprofen Sodium Patches(reference product) and Loxoprofen Sodium Patches(test product ) in people with Osteoarthritis and Muscle Pain, run by Frontier Biotechnologies Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng Yao (+86 02569760330, yaocheng@frontierbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of loxoprofen and its trans-OH (time frame: 0-72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.