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This clinical trial is a randomized, double-blind, single-center, placebo-controlled and multiple-dose escalation Pharmacokinetics study
The main purpose of this trial is to evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of VC005 Tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VC005 Tablets Dose escalation groups | Experimental | VC005 Tablets groups Repeat doses |
|
| VC005 Tablets Placebo groups | Placebo Comparator | VC005 Tablets Placebo groups Repeat doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VC005 tablets | Drug | VC005 groups repeat administration for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Day 2 | |
| Area under the plasma concentration versus time curve (AUC) | Day 2 | |
| Peak time in plasma(Tmax) | Day 2 | |
| Area under the plasma concentration versus time curve during the dosing interval(AUC0-Ï„) | Day 9 | |
| minimum plasma concentration at steady state(Cmin,ss) | Day 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| VC005 Placebo tablets |
| Drug |
VC005 placebo groups repeat administration for 7 days |
|