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This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed condition | Experimental | Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fed condition |
|
| Fasted condition | Experimental | Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fasted condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPM3770164 sustained release tablet | Drug | Single-dose of 30 mg of LPM3770164 sustained release tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Predose and up to 240 hours postdose | |
| Area Under the Curve from time 0 to the last measurable concentration (AUC0-t) | Predose and up to 240 hours postdose | |
| Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf) | Predose and up to 240 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse event | from baseline to day 25 | |
| Time to maximum concentration (Tmax) | Predose and up to 240 hours postdose | |
| Half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hufang Li, Doctor | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | China |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D000071057 | Tardive Dyskinesia |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Predose and up to 240 hours postdose |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004409 | Dyskinesia, Drug-Induced |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |