The Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
NCT Number: NCT04667429
Multiple Dose Safety, Tolerability, PK ,PD and Food Effect Study of HEC83518 in Healthy Subjects
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
16.Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
HEC83518 40mg will be taken orally fasted or with food
HEC83518 will be taken orally before sleep for 15 days
The placebo will be administered before sleep for 15 days.
Time frame: up to 34 days
To assess the safety and tolerability of therapy
Time frame: up to 72 hours
Time frame: up to 72 hours
Time frame: up to 72 hours
Time frame: up to 72 hours
Time frame: up to 72 hours
Time frame: up to 72 hours
Time frame: up to 72 hours
Time frame: up to 60 hours
Time frame: up to 72 hours
Time frame: up to 72 hours
Time frame: up to 24 hour
This is a 9-point scale (1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy,7 = sleepy - but no difficulty remaining awake,and 9 = extremely sleepy - fighting sleep).The score of KSS scale will be recorded at different time and the change score compared with baseline will be analysed to evaluated the start of effective time, the most effective time and the recovered time to baseline.
Time frame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Time frame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Time frame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Time frame: during the sleep time on the night(from 22:00-22:30 to the next morning wake-up)
Sunshine Lake Pharma Co., Ltd.
Industry
A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study of HEC83518 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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