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| ID | Type | Description | Link |
|---|---|---|---|
| R064766SCH1013 | Other Identifier | Xian-Janssen Pharmaceutical Ltd., China |
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CFDA announced Xi'An Risperdal as reference drug, no need for this BE trial from both scientific and ethical perspective.
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The primary purpose of this study is to assess the bioequivalence of Xian Risperdal compared with Gurabo Risperdal in Chinese healthy participants under fasting and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence: AB | Experimental | Participants in cohort 1 (fasting) and cohort 2 (fed) will receive 1 milligram (mg) risperidone administered as Xian Risperdal (test) 1*1 mg oral tablet (Treatment A) on Day 1 in Period 1 followed by 1 mg risperidone administered as Gurabo Risperdal (reference) 1*1 mg oral tablet (Treatment B) on Day 1 in period 2. There will be a washout period of at least 10 days between treatments. |
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| Treatment Sequence: BA | Experimental | Participants in cohort 1 (fasting) and cohort 2 (fed) will receive Treatment B on Day 1 in period 1 followed by Treatment A on Day 1 in period 2. There will be a washout period of at least 10 days between treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone: Xian Risperdal (test) | Drug | Participants will receive 1*1 mg tablet of Xian Risperdal under fasting or fed condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) will be assessed. | Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose |
| Area Under Concentration-Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) | Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation. | Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. AUC (0-infinity) will be assessed. | Pre-dose, 15, 30, 45 minutes post-dose, and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 48, 72 and 96 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to approximately 29 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
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| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| Beijing Shijitan Hospital | Beijing | 100036 | China |
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| Risperidone: Gurabo Risperdal (reference) | Drug | Participants will receive 1*1 mg tablet of Gurabo Risperdal under fasting or fed condition. |
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