Shanghai Xuhui Central Hospital
Shanghai, China
NCT Number: NCT04625361
The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Part2:Mulltiple doses once daily, up to 8 days
Time frame: Part 1:up to 6 days; Part 2: up to 13 days.
To investigate the safety and tolerability of HEC122505MsOH by assessment of AEs (non-serious and serious) following administration of oral HEC122505MsOH tablets
Time frame: up to 120 hours
Maximum Plasma Concentration(Cmax)
Time frame: up to 120 hours
Area Under the Curve(AUC)
Time frame: up to 120 hours
Maximum Peak Time(Tmax)
Time frame: up to 120 hours
Elimination Half-life(t½)
Time frame: up to 120 hours
Mean Residence Time(MRT)
Time frame: up to 120 hours
Apparent Clearance(CL/F)
Time frame: up to 120 hours
Apparent Volume of Distribution(Vz/F)
Time frame: up to 120 hours
Elimination Rate Constant(Kel)
Time frame: up to 120 hours
Monoamine Oxidase B(MAO-B)
Time frame: up to 120 hours
Monoamine Oxidase A(MAO-A)
Sunshine Lake Pharma Co., Ltd.
Industry
A Single Center, Randomized, Double-Blind, Placebo-Controlled Study of Single/Multiple Ascending Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Single Center, Randomized, Double-Blind, Two Periods, Crossover, Food Effect Study of HEC122505MsOH Tablets in Healthy Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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