NCT03850834

Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject

A Multiple-dose Study to Evaluate the Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese healthy subjects

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Ammoxetine Hydrochloride Enteric-coated Tablets	There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested
DRUG	placebo enteric-coated tablets	There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested

Timeline

• Start date: 2019-03-10
• Primary completion: 2019-05-31
• Completion: 2019-10-31
• First posted: 2019-02-22
• Last updated: 2019-02-22