NCT04667429

the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets

A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study of HEC83518 Tablets in Healthy Chinese Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects

Conditions

• Insomnia

Interventions

Type	Name	Description
OTHER	Food	HEC83518 40mg will be taken orally fasted or with food
DRUG	HEC83518	HEC83518 will be taken orally before sleep for 15 days
DRUG	placebo	The placebo will be administered before sleep for 15 days.

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-08-01
• Completion: 2021-10-01
• First posted: 2020-12-14
• Last updated: 2021-05-10

Locations

1 site across 1 country: China