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| Name | Class |
|---|---|
| Shenyang Sunshine Pharmaceutical Co., LTD. | INDUSTRY |
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Main objective: To evaluate the pharmacokinetics of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
Secondary objective: To evaluate the safety profile of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetics study of single and multiple administration | Experimental | During the study session, 30 healthy subjects will be administered a single and multiple dose of narfurine hydrochloride orally disintegrating tablets 5 µg (2.5 µg/table) to evaluate the pharmacokinetic parameters and the safety profile. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| narfurine hydrochloride orally disintegrating tablets | Drug | Subjects swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM on D1; swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM starting on D4. Dosing for 7 consecutive days (D10 last dose in the morning). |
| Measure | Description | Time Frame |
|---|---|---|
| AUC AUC | Area Under the Plasma Concentration-time Curve | Day1 to Day13 |
| Cmax | Maximum Observed Plasma Concentration | Day1 to Day13 |
| Tmax | Time to Reach the Maximum Plasma Concentration | Day1 to Day13 |
| t1/2 | Elimination half-life | Day1 to Day13 |
| Kel | Elimination rate constant | Day1 to Day13 |
| CL/F CL/F | Apparent clearance | Day1 to Day13 |
| Vd/F | Apparent distribution volume based on terminal elimination phase | Day1 to Day13 |
| MRT | Mean residence time | Day1 to Day13 |
| Css_max | Steady state peak concentration | Day1 to Day13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jian liu, master | The First Affiliated Hospital,ZheJiang Univercity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,ZheJiang Univercity | Hanzhou | Zhejiang | 310000 | China |
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|
| Css_min |
Steady state Valley concentration |
| Day1 to Day13 |
| Css_av | Steady state average concentration | Day1 to Day13 |
| DF | Volatility index | Day1 to Day13 |
| Safety and tolerance indicators | AE and SAE | Day1 to Day13 |