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To evaluate the safety and pharmacokinetics of GV-971 capsules after oral a single or multiple doses of 900 mg, 1200 mg and 1500 mg in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GV-971 900 mg | Experimental | 900 mg oral |
|
| GV-971 1200 mg | Experimental | 1200 mg oral |
|
| GV-971 1500 mg | Experimental | 1500 mg oral |
|
| Placebo | Placebo Comparator | Oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GV-971 | Drug | Oral GV-971 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | Cmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 2 day and 7 day |
| Half life time (T1/2) | T1/2 will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 2 day and 7 day |
| Area under the plasma concentration versus time curve (AUC) | AUC will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 2 day and 7 day |
| Time to the peak drug concentration (Tmax) | Tmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 2 day and 7 day |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) | AE occurred after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianliang Xin, Ph D | Contact | +86-21-50504988 | 1097 | xinxianliang@gv-ri.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Yu, MD | Shanghai Xuhui Center hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| C000710388 | GV-971 |
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| Placebo | Drug | Oral Placebo |
|