A Phase 1 interventional study of YZJ-1139 tablets and Escitalopram oxalate tablets in Insomnia and Central Nervous System, sponsored by Shanghai Haiyan Pharmaceutical Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Phase 1, Interventional, and Basic science
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 24 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Shanghai Haiyan Pharmaceutical Technology Co., Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: YZJ-1139 tablets · Drug: Escitalopram oxalate tablets · Drug: YZJ-1139 simulated tablets
Drug: Escitalopram oxalate tablets · Drug: YZJ-1139 simulated tablets
YZJ-1139 tablets are administered orally single dose
•oral tablet, QD
oral tablet, QD
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to Day 11
Maximum Observed Plasma Concentration (Cmax) of YZJ-1139
Cmax is defined as the maximum concentration of drug.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to Day 11
Apparent Terminal Elimination Half-life (t1/2) of Entrectinib
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to Day 11
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 to Day 16
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Haiyan Pharmaceutical Technology Co., Ltd.