Clinical Trial Details
| Trial ID: | L4894 |
| Source ID: | NCT02361138 |
| Associated Drug: | Shr3824 |
| Title: | The PK/PD Study of Multiple Dose of SHR3824 in Healthy Volunteers |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: SHR3824|DRUG: Placebo |
| Outcome Measures: | Primary: AUC(Area under the curve) of SHR3824., day1 and day11 to day 13.|Cmax(the maximum concentration) of SHR3824., day1 and day11 to day 13.|Tmax(the time reaching maximum concentration) of SHR3824., day1 and day11 to day 13.|Halflife of SHR3824., day1 and day11 to day 13.|CL/F of SHR3824., day1 and day11 to day 13.|V/F of SHR3824., day1 and day11 to day 13.|Accumulation ratio of SHR3824, Up to day 13.|Urine glucose concentration of SHR3824., day1 and day11|Plasma glucose concentration of SHR3824., day1 and day11 | Secondary: Adverse events, vital signs, physical exams , ECG, clinical labs, Days -14 to -1, 0, 13.|Serum creatinine, Days -14 to -1, 0, 2, 9, 13. |
| Sponsor/Collaborators: | Sponsor: Jiangsu HengRui Medicine Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 48 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-12 |
| Completion Date: | 2014-05 |
| Results First Posted: | |
| Last Update Posted: | 2015-02-11 |
| Locations: | Shanghai Xuhui Central Hospital, Shanghai, Shanghai, 200030, China |
| URL: | https://clinicaltrials.gov/show/NCT02361138 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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