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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loxoprofen Sodium Patches(reference product) | Drug | Single dose of one patch in each period; Apply for 24 hours each time |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Yao | Contact | +86 02569760330 | yaocheng@frontierbiotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng Yao | Frontier Biotechnologies Inc. | Study Director |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Loxoprofen Sodium Patches(test product ) | Drug | Single dose of one patch in each period; Apply for 24 hours each time |
|
|
| 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 |
| D009135 |
| Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |