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This study is an open-label, single-center, two-period, two-sequence crossover study to assess the bioequivalence of SP-01 (Sancuso®: Granisetron Patch) manufactured at two different sites. Either the test product, namely SP-01-K, or reference product, namely SP-01-A, will be applied to the subject once in each period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (SP-01-K) | Experimental | Application of SP-01 manufactured by Site K (SP-01-K) for 6 days followed by washout period for 21 days followed by application of SP-01 manufactured by Site A (SP-01-A) for 6 days |
|
| Group 2 (SP-01-A) | Active Comparator | Application of SP-01 manufactured by Site A (SP-01-A) for 6 days followed by washout period for 21 days followed by application of SP-01 manufactured by Site K (SP-01-K) for 6 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron) | Drug | Single application for 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed drug concentration (Cmax) | Maximum observed drug concentration in plasma | 11 days |
| Area under the concentration-time curve (AUC) 0-t | Area under the plasma concentration-time curve from time zero to time t, where t is the last time point with non-zero concentration | 11 days |
| AUC0-∞ | Area under the plasma concentration-time curve from time zero to time infinity | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach Cmax (Tmax) | Time to reach the maximum observed drug concentration in plasma | 11 days |
| Terminal elimination rate constant (λZ) | Apparent terminal phase rate constant, where λZ is the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase |
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Inclusion Criteria:
Han Chinese male or female subject, with all of his/her biological parents and grandparents are of Han Chinese ethnicity (who do not belong to any Chinese minorities)
Subject aged between 18 and 55 years, inclusive, at the time of signing the informed consent form
Body weight ≥ 45 kg and body mass index (BMI) of 18 to 25 kg/m2, inclusive.
Generally in good health with no clinically significant abnormality. Clinically insignificant abnormalities may be acceptable at the discretion of the investigator.
Female subject.
Male subject.
Ability to understand the nature, scope and possible consequences of participation in the study
Willing to comply with the study procedures and restrictions
Willing to give written informed consent voluntarily
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Man Yung Cheung | Phase 1 Clinical Trials Centre, The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase 1 Clinical Trials Centre, The University of Hong Kong | Hong Kong | Hong Kong |
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| SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron) | Drug | Single application for 6 days |
|
| 11 days |
| Elimination half-life (t1/2) | The time required for the observed drug concentration in plasma to reach half of its original value | 11 days |
| Adverse event | Incidence of adverse events | 38 days |
| Adhesion | Mean adhesion score, which is the average of adhesion scores of a subject in a period | 7 days |