NCT04591301

The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of HEC113995 PA•H2O Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Male and Female Subjects

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	HEC113995 PA•H2O tablets	Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
DRUG	Placebo tablets	Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Timeline

• Start date: 2019-07-04
• Primary completion: 2019-12-06
• Completion: 2019-12-06
• First posted: 2020-10-19
• Last updated: 2020-10-28

Locations

1 site across 1 country: China