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A HR20031 FE Study on Healthy Subjects

NCT05692934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-04

No results posted yet for this study

Summary

The purpose of this study is to assess the effect of food on the single-dose PK of SHR3824, SP2086 and metformin in the HR20031 FDC tablets in healthy subjects.

Conditions

Interventions

DRUG

HR20031 FDC

Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fed state .

DRUG

HR20031 FDC

Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fast state.

DRUG

HR20031 FDC

Subjects will receive treatment S HR20031 FDC 5/50/750 mg\*2 in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg\*2 in the fed state.

DRUG

HR20031 FDC

Subjects will receive treatment HR20031 FDC 5/50/750 mg\*2 in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg\*2 in the fast state.

Sponsors & Collaborators

  • Shandong Suncadia Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-03-11
Completion
2023-03-11

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05692934 on ClinicalTrials.gov