| Trial ID: | L4079 |
| Source ID: | NCT06422039
|
| Associated Drug: |
Hrs-7535（D）Tablets
|
| Title: |
Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: HRS-7535（D）Tablets|DRUG: HRS-7535（C）Tablets
|
| Outcome Measures: |
Primary: PK parameters：Cmax, 0 hour to 72 hours after the last dosing|PK parameters：AUC0-t, 0 hour to 72 hours after the last dosing|PK parameters：AUC0-∞, 0 hour to 72 hours after the last dosing|Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal, 0 hour to 72 hours after the last dosing|Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status, 0 hour to 72 hours after the last dosing | Secondary: PK parameters：Tmax, 0 hour to 72 hours after the last dosing|PK parameters： t1/2, 0 hour to 72 hours after the last dosing|PK parameters： CL/F, 0 hour to 72 hours after the last dosing|PK parameters： V/F, 0 hour to 72 hours after the last dosing|Incidence and severity of adverse events (AEs), from screening to 72 hours after the last dosing
|
| Sponsor/Collaborators: |
Sponsor: Shandong Suncadia Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-05-15
|
| Completion Date: |
2024-06-15
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-20
|
| Locations: |
The Second Hospital of Anhui Medical Uniersity, Hefei, Anhui, 230601, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06422039
|
