| Trial ID: | L4147 |
| Source ID: | NCT04540016
|
| Associated Drug: |
[14c]Hsk7653
|
| Title: |
Mass Balance and Biotransformation of [14C]HSK7653 in Human
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type II Diabetes
|
| Interventions: |
DRUG: [14C]HSK7653
|
| Outcome Measures: |
Primary: Percentage of cumulative drug excretion of [14C]HSK7653 on biological specimens(urine and faeces) accounting for total radiation drug dose, Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of \[14C\]HSK7653，calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces)., From the start of administration to 50 day after administration|Peak concentration (Cmax), Pharmacokinetic Measures, From the start of administration to 50 day after administration|Area under the concentration-time curve (AUC0-t, AUC0-∞), Pharmacokinetic Measures, From the start of administration to 50 day after administration |
|
| Sponsor/Collaborators: |
Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd | Collaborators: First Affiliated Hospital of Suzhou Medical College
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
6
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-11-15
|
| Completion Date: |
2021-01-21
|
| Results First Posted: |
|
| Last Update Posted: |
2022-12-12
|
| Locations: |
the First Affilicated Hospital of Soochow University, Suzhou, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04540016
|
