NCT05108350

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

A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-11-09
• Primary completion: 2021-12-03
• Completion: 2021-12-10
• First posted: 2021-11-04
• Last updated: 2021-11-04