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This study is a phaseâ… study to determine the acute effects of TPN171H on semen function in healthy male subjects.
Safety Study in male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 9 subjects receive 10 mg TPN171H for Period 1; Placebo for Period 2 |
|
| Cohort 2 | Experimental | 9 subjects receive Placebo for Period 1; 10 mg TPN171H for Period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPN171H 10mg | Drug | Subjects were given 10mg TPN171H tablet with 240 mL warm water under fasting condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on semen function | The parameters of semen routine analysis were compared between TPN171H tablets and placebo. | 1.5 hours after taking the medicine |
| Seminal plasma exposure | TPN171H exposure in seminal fluid | 1.5 hours after taking the medicine |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study | From administration of study drug through 3 days after last administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Jiang | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40181588 | Derived | Yang Y, Zhang Z, Li L, Jiang Z, Juan J, Duan H, Wang Z, Jiang H. Evaluation of the acute effects of single-dose TPN171 on semen quality in healthy Chinese male volunteers. Br J Clin Pharmacol. 2025 Aug;91(8):2401-2408. doi: 10.1002/bcp.70049. Epub 2025 Apr 3. |
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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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| TPN171H Placebo | Drug | Subjects were given Placebo with 240 mL warm water under fasting condition. |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |