NCT04598607

Tolerability and Pharmacokinetics of Hypidone Hydrochloride in Healthy Subjects

A Multiple-Dose Study to Evaluate the Tolerability and Pharmacokinetics of Hypidone Hydrochloride Tablets in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Zhejiang Huahai Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the tolerability and pharmacokinetics of Hypidone Hydrochloride by multiple doses in 36 healthy male and female subjects who are of 18 to 55 years old.

Detailed description

This is a double-blind, placebo-controlled, randomized, multiple-dose, single center study. 36 male and female healthy subjects will be enrolled in this study. Within 14 days prior to study drug administration, subjects will be screened based on the inclusion and exclusion criteria. The study will be performed in 3 groups of 12 subjects each. In each group of 12 subjects, 10 subjects will be randomly assigned to receive Hypidone Hydrochloride and 2 subjects to receive matching placebo.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Hypidone Hydrochloride tablets	30mg(10mg×3), 40mg(10mg×4) or 50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3\~8.
DRUG	Placebo	3, 4 or 5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3\~8.

Timeline

• Start date: 2020-10-30
• Primary completion: 2021-01-11
• Completion: 2021-01-15
• First posted: 2020-10-22
• Last updated: 2021-08-25

Locations

1 site across 1 country: China