Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-26 @ 12:07 PM
Study NCT ID:
NCT05108350
Status:
UNKNOWN
Last Update Posted:
2021-11-04
First Post:
2021-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: