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COMPLETED
NCT07588646
PHASE1

Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects

Sponsor: Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male subjects.

Official title: A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2021-06-29

Completion Date

2021-11-30

Last Updated

2026-05-15

Healthy Volunteers

Yes

Interventions

DRUG

HEC585

DDI of HEC585 and Pirfenidone:HEC585, once daily,D5-D14 and D18-D27; DDI of HEC585 and Nintedanib:HEC585,once daily,D14-D23 and D27-D36

DRUG

Nintedanib

DDI of HEC585 andNintedanib:Nintedanib,twice a day,D1-D7 and D30-D36

DRUG

Pirfenidone

DDI of HEC583 and Pirfenidone: Pirfenidone:three times a day,D1-D3 and D25-D27

Locations (1)

Shanghai Xuhui Central Hospital

Shanghai, China