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A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects

NCT05108350 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-11-04

No results posted yet for this study

Summary

The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.

The primary objective is to evaluate bioequivalence of SHR3824 and Metformin in healthy Chinese subjects in the fed state.

The secondary objective is to evaluate the safety of HR20033 FDC tablet in healthy Chinese subjects.

Conditions

  • Type II Diabetes

Interventions

DRUG

T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR

SHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment T1 followed by 7 days washout and then receive treatment R1+R.

DRUG

T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR

SHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment R1+R followed by 7 days washout and then receive treatment T1.

DRUG

T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR

SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment T2 followed by 7 days washout and then receive treatment R2+R.

DRUG

T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR

SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment R2+R followed by 7 days washout and then receive treatment T2.

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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2021-12-03
Completion
2021-12-10

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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 NCT05108350 on ClinicalTrials.gov