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This clinical trial consists of two parts:1. a randomized, double-blind, single-center, placebo-controlled, dose-escalation PK study; 2. food effects and drug metabolism transformation study.
The main purpose of this trial is to evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Food effects of VC005 Tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VC005 Tablets Dose escalation groups: 1、5、10、25、50、100mg | Experimental | VC005 Tablets 1、5、10、25、50、100mg, qd |
|
| VC005 Tablets Placebo Dose escalation groups: 1、5、10、25、50、100mg | Placebo Comparator | VC005 Tablets Placebo 1、5、10、25、50、100mg, qd |
|
| VC005 Tablets food effects group | Experimental | VC005 Tablets, qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VC005 Tablets | Drug | VC005 Tablets 1、5、10、25、50、100mg single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Day 4 | |
| Area under the plasma concentration versus time curve (AUC) | Day 4 | |
| Peak time in plasma(Tmax) | Day 4 | |
| Accumulative urine excretion rate | Day 4 | |
| Accumulative fecal excretion rate | Day 4 |
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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 | 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 Tablets Placebo | Drug | VC005 Tablets Placebo 1、5、10、25、50、100mg single dose |
|
| VC005 Tablets food effects group | Drug | VC005 Tablets qd per period, for two periods |
|