A Phase 1 interventional study of Loxoprofen Sodium Patches(reference product) and Loxoprofen Sodium Patches(test product ) in Osteoarthritis, Muscle Pain and Swelling Muscle, sponsored by Frontier Biotechnologies Inc.. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by Frontier Biotechnologies Inc. · Phase 1, Interventional, and Treatment
This study was a single-center, randomized, open-label, two-agent, two-cycle, double-cross bioequivalence trial.
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Frontier Biotechnologies Inc. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 )
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 )
Single dose of one patch in each period; Apply for 24 hours each time
Also known as: Loxonin®
Single dose of one patch in each period; Apply for 24 hours each time
Also known as: FB3002
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.
Time frame: 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.
Time frame: 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.
Time frame: 0-72 hours
Adverse Events
All of the adverse events will be reported
Time frame: 0-14 days
Tmax of loxoprofen and its trans-OH
Time to reach maximum plasma concentration
Time frame: 0-72 hours
t1/2 of loxoprofen and its trans-OH
Apparent terminal elimination half-life
Time frame: 0-72 hours
λz
Apparent terminal elimination rate constant
Time frame: 0-72 hours
AUC_%Extrap
Percentage of AUCINF(_obs, _pred) due to extrapolation from Tlast to infinity
Time frame: 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.
Time frame: 0-14 days
No study locations are listed for this record.
Start is estimated for Jul 2024; primary completion for Aug 2024, 1 month later.
Of 35 industry-sponsored phase 1 interventional studies under Osteoarthritis, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 1 month is below that.
Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 9 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Loxoprofen
Frontier Biotechnologies Inc.