NCT03748745

A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects

A Single-center, Open-label, Steady-state Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the drug-drug interaction of SH229 tablets and Daclatasvir dihydrochloride tablets. The study also evaluates the pharmacokinetics and tolerability of co-administration of SH229 tablets and Daclatasvir dihydrochloride tablets in healthy subjects. This study provides evidence for the designing of following clinical trial protocols.

Detailed description

A total of 28 evaluable healthy subjects will be enrolled in this study. The dose of SH229 is 600 mg. The dose of Daclatasvir dihydrochloride is 60 mg.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	SH229	tablet, oral, 600 mg once daily for day 1 to day 14
DRUG	SH229	tablet, oral, 600 mg once daily for day 8 to day 14
DRUG	Daclatasvir dihydrochloride	tablet, oral, 60 mg once daily for day 8 to day 14
DRUG	Daclatasvir dihydrochloride	tablet, oral, 60 mg once daily for day 1 to day 14

Timeline

• Start date: 2018-11-19
• Primary completion: 2018-12-25
• Completion: 2018-12-25
• First posted: 2018-11-21
• Last updated: 2019-08-13

Locations

1 site across 1 country: China