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The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil (XZP-5849)in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study
XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66 Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose level). Each subject will participate in only one cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fadanafil | Experimental | 8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose |
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| Placebo | Placebo Comparator | 8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fadanafil | Drug | Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiogram (ECG) | To evaluate subject ECG Changing information | Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing. |
| Pharmacokinetic Parameter AUC(0-24) | AUC(0-24) of Fadanafile is area under the curve | Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 4, 6,8,12, 24,36 hours after Dosing |
| Blood Pressure and Heart Rate | To evaluate subject Blood Pressure and Heart Rate Changing information | Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haiyan Li, Doctor | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haiyan Li | Beijing | Beijing Municipality | 100076 | China |
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| ID | Term |
|---|---|
| C056565 | 1,2-dibenzoyl-tert-butylhydrazine |
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8 dose groups within 12.5mg~500mg for single dose tolerability study to carrried out from low-dose group to high dose group
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| Placebo | Drug | Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose |
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