Trials / Completed
CompletedNCT05692934
A HR20031 FE Study on Healthy Subjects
A Study to Assess the Effect of Food on HR20031 Tablet in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Shandong Suncadia Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the effect of food on the single-dose PK of SHR3824, SP2086 and metformin in the HR20031 FDC tablets in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HR20031 FDC | Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fed state . |
| DRUG | HR20031 FDC | Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fast state. |
| DRUG | HR20031 FDC | Subjects will receive treatment S HR20031 FDC 5/50/750 mg\*2 in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg\*2 in the fed state. |
| DRUG | HR20031 FDC | Subjects will receive treatment HR20031 FDC 5/50/750 mg\*2 in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg\*2 in the fast state. |
Timeline
- Start date
- 2023-01-31
- Primary completion
- 2023-03-11
- Completion
- 2023-03-11
- First posted
- 2023-01-20
- Last updated
- 2023-04-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05692934. Inclusion in this directory is not an endorsement.