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Primary Objective:
1) To evaluate the pharmacodynamic interaction between YZJ-1139 tablets and Escitalopram oxalate tablets in healthy subjects; 2) To evaluate the pharmacokinetic interaction between YZJ-1139 tablets and Escitalopram oxalate tablets in healthy subjects; To observe the safety of YZJ-1139 tablets taken together with Escitalopram oxalate tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YZJ-1139 tablets | Drug | YZJ-1139 tablets are administered orally single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| saccade eye movement test | Saccadic eye movements were evaluated by using a computer-based electronystagmography system.To assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets. | From Day 1 to Day 11 |
| body swing test | Body swing test was measured with an apparatus, which integrates the amplitude of unidirectional body sway. To assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets. | From Day 1 to Day 11 |
| selective reaction time test | Subjects selected buttons in different directions according to Chinese character prompts on a computer screen,assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets. | From Day 1 to Day 11 |
| number symbol conversion test | Subjects click the corresponding number according to the corresponding relationship between the given symbol and the number. To assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets. | From Day 1 to Day 11 |
| word memory test | Subjects recall presented words at specific times.To assess the change in scores for escitalopram oxalate tablets combined with YZJ-1139 tablets relative to YZJ-1139 tablets simulant and YZJ-1139 tablets. | From Day 1 to Day 11 |
| Maximum Observed Plasma Concentration (Cmax) of YZJ-1139 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
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Drug interaction
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| Escitalopram oxalate tablets |
| Drug |
•oral tablet, QD |
|
| YZJ-1139 simulated tablets | Drug | oral tablet, QD |
|
Cmax is defined as the maximum concentration of drug. |
| From Day 1 to Day 11 |
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of YZJ-1139 | AUC0-t is defined as the concentration of drug from time zero to the last observable concentration. | From Day 1 to Day 11 |
| Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of YZJ-1139 | AUC0-∞ is defined as the concentration of drug extrapolated to infinite time. | From Day 1 to Day 11 |
| Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib | Tmax is defined as the time (observed time point) of Cmax. | From Day 1 to Day 11 |
| Apparent Terminal Elimination Half-life (t1/2) of Entrectinib | From Day 1 to Day 11 |
| Apparent Oral Clearance (CL/F) of Entrectinib | CL/F is defined as the apparent oral clearance following administration of the drug. | From Day 1 to Day 11 |
| The Apparent Volume of Distribution (Vz/F) of Entrectinib | Vz/F is defined as the apparent volume of distribution of the drug. | From Day 1 to Day 11 |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 to Day 16 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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