NCT04623814

the Safety, Tolerability, and Pharmacokinetics Study of HEC113995

HEC113995-A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
OTHER	Food	HEC113995 20mg will be taken orally fasted or with food
DRUG	HEC113995	HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days
DRUG	placebo	The placebo will be administered fasted or with food for 10 days.

Timeline

• Start date: 2020-03-30
• Primary completion: 2020-08-12
• Completion: 2020-08-12
• First posted: 2020-11-10
• Last updated: 2020-11-25

Locations

1 site across 1 country: China