Phase 1Status unknown
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
- Sponsor
- Shandong Suncadia Medicine Co., Ltd. (Industry)
- Enrolment
- 80 planned
- Conditions
- Type II Diabetes
- Interventions
- T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR; T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR; T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR; T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
- Ages
- adults
- Registry
- NCT05108350
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax
- Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-t
- Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-inf (if applicable)
History
Study completion
Primary completion
Started
Registered