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

NCT07588646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2021-11-30
Completion
2021-11-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07588646 on ClinicalTrials.gov