NCT04596007

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC83518 Tablets in Chinses Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	HEC83518 tablets	Each dose of HEC83518 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
DRUG	Placebo	placebo

Timeline

• Start date: 2020-04-01
• Primary completion: 2020-09-10
• Completion: 2021-06-30
• First posted: 2020-10-22
• Last updated: 2021-05-10

Locations

1 site across 1 country: China