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The purpose of this study is to evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc interval of a single oral dose of FXS5626 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FXS5626 | Experimental | FXS5626 75mg、250mg、400mg; single dose, oral |
|
| Placebo | Placebo Comparator | single dose, oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FXS5626 tablet | Drug | FXS5626 75mg、250mg、400mg, single dose, oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on QTcF between baseline and post-dose treatment of FXS5626 | The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF | 45 min before administration and 24 hours after administration |
| To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [Safety and Tolerability] of single ascending oral dose of FXS5626 in healthy adults. | The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests | Approximately 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration and pharmacokinetic parameters | Cmax | 10 min before administration and 48 hours after administration |
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Inclusion Criteria:
Exclusive Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Xue, PHD | Contact | 86 010-58115037 | roserebel@126.com | |
| Wenyuan Qi | Contact | 86 010-85138673 | qiwenyuan.bjhmoh@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
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| Placebo tablet |
| Drug |
single dose, oral |
|