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It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPN171H | Experimental | 5 mg TPN171H tablets,single dose,oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPN171H | Drug | 5 mg TPN171H tablets,single dose,oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of Participants With treatment-related Adverse Events and Serious Adverse Events | 7 days after dosing |
| Pharmacokinetic parameter of TPN171H:Tmax | Pharmacokinetic parameter of TPN171H:Tmax | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:Cmax | Pharmacokinetic parameter of TPN171H:Cmax | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:T1/2 | Pharmacokinetic parameter of TPN171H:T1/2 | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:AUC0-t | Pharmacokinetic parameter of TPN171H:AUC0-t | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:AUC0-∞ | Pharmacokinetic parameter of TPN171H:AUC0-∞ | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:AUC0-24h | Pharmacokinetic parameter of TPN171H:AUC0-24h | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:Ke | Pharmacokinetic parameter of TPN171H:Ke | 48 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gangyi Liu | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Pharmacokinetic parameter of TPN171H:Vd | Pharmacokinetic parameter of TPN171H:Vd | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:MRT | Pharmacokinetic parameter of TPN171H:MRT | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:CL/F | Pharmacokinetic parameter of TPN171H:CL/F | 48 hours after dosing |
| Pharmacokinetic parameter of TPN171H:BRPP | Pharmacokinetic parameter of TPN171H:BRPP | 48 hours after dosing |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |