Clinical Trial Details
| Trial ID: | L4615 |
| Source ID: | NCT04907006 |
| Associated Drug: | Sy-004 Capsule |
| Title: | A Food-drug Interaction Study of SY-004 in Healthy Subjects |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: SY-004 capsule |
| Outcome Measures: | Primary: AUC0-t, Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC) 0-t of SY-004 in human plasma., 8 days|AUC0-∞, Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC)0 - ∞ of SY-004 in human plasma., 8 days|Cmax, Under fasting and high-fat diet, Peak Plasma Concentration (Cmax) of SY-004 in human plasma., 8 days | Secondary: Tmax、t1/2z、CLz/F, Under fasting and high-fat diet, Peak time(Tmax) of SY-004 in human plasma., 8 days|t1/2z, Under fasting and high-fat diet, Half life (T1/2z) of SY-004 in human plasma., 8 days|CLz/F, Under fasting and high-fat diet, clearance (Cl) of SY-004 in human plasma., 8 days |
| Sponsor/Collaborators: | Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 24 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2021-08-31 |
| Completion Date: | 2021-10-11 |
| Results First Posted: | |
| Last Update Posted: | 2022-05-18 |
| Locations: | XIE Haitang, Wuhu, Anhui, 241000, China |
| URL: | https://clinicaltrials.gov/show/NCT04907006 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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