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This study is an open-label, randomized, cross-over design with two single-dose treatment periods and a washout of at least 3~5 days in between each treatment visit. The study period consists of 3 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose treatment), Visit 3 (second single-dose treatment).
Target subject population is healthy subjects aged 18-45 years. Following an overnight fast of at least 10 hours, a single dose of 90mg salvianolic acid A will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| After meal | Experimental | Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake). |
|
| Fasting | Experimental | Each subject will receive a single oral dose of 90 mg salvianolic acid A. Each dose will be administered at the end of a 10-hour fast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salvianolic acid A | Drug | Following an overnight fast of at least 10 hours, a single dose of 90 mg salvianolic acid A will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| Measure | Description | Time Frame |
|---|---|---|
| The Effect of Food Timing (Fasting and After Meal) on Pharmacokinetics of salvianolic acid A in Healthy Subject | To assess the effect of food by evaluating the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last)) | Hour 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yimin Cui, Ph.D | Contact | 010-66110802 | cuiymzy@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaocong Pang | Recruiting | Beijing | 100050 | China |
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| ID | Term |
|---|---|
| C066201 | salvianolic acid A |
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