| Trial ID: | L2033 |
| Source ID: | NCT05893576
|
| Associated Drug: |
Hrs9531
|
| Title: |
A Relative Bioavailability Study of HRS9531 in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HRS9531|DRUG: HRS9531
|
| Outcome Measures: |
Primary: Area Under the Concentration versus time curve (AUC) of HRS953, Start of treatment up to Day 43|Maximum Concentration (Cmax) of HRS9531, Start of Treatment up to Day 43|Calculate the ratio of bioavailability between the new formulation and original formulation of HRS9531 according to the equation F (relative bioavailability) =AUCT·DR/AUCR·DT×100%, Start of Treatment up to Day 43 | Secondary: Time to maximum concentration (Tmax), Start of Treatment up to Day 43|Apparent terminal half-life (t1/2), Start of Treatment up to Day 43|Clearance (CL/F), Start of Treatment up to Day 43|Apparent volume of distribution (VzF), Start of Treatment up to Day 43|Incidence and severity of adverse events, Screening period up to Day 43
|
| Sponsor/Collaborators: |
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-05-15
|
| Completion Date: |
2023-09-04
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| Results First Posted: |
|
| Last Update Posted: |
2023-10-24
|
| Locations: |
Central hospital affiliated to Shandong first mecical university, Jinan, Shandong, 250014, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05893576
|
