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A HR20031 BE Study on Healthy Subjects

NCT05682495 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-04-07

No results posted yet for this study

Summary

The purpose of this study is to assess the bioequivalence between HR20031 FDC tablet and co-administration of SHR3824 tablets, SP2086 tablets and metformin XR tablets.

Conditions

Interventions

DRUG

ARM A

Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout ，then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout and then receive treatment HR20031 FDC 10/100/1000 mg.

DRUG

ARM B

Subjects will receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout ，then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2.

DRUG

ARM C

Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2.

DRUG

ARM D

Subjects will receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout ，then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout and then receive treatment HR20031 FDC 5/50/750 mg\*2.

DRUG

ARM E

Subjects will receive treatment HR20031 FDC 5/50/750 mg\*2 followed by 7 days washout ，then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout and then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3.

DRUG

ARM F

Subjects will receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg\*2 followed by 7 days washout and then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3.

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
2023-04-04
Completion
2023-04-04

Countries

  • China

Study Locations

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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 NCT05682495 on ClinicalTrials.gov