Clinical Trial Details
| Trial ID: | L5502 |
| Source ID: | NCT02353975 |
| Associated Drug: | Shr3824 |
| Title: | Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: SHR3824 |
| Outcome Measures: | Primary: The maximum plasma concentration (Cmax) of SHR3824, Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state, Day 1-4 on visit 2 and visit 3|The area under the plasma concentration-time curve (AUC) of SHR3824, AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state, Day 1-4 on visit 2 and visit 3|The accumulative excretion rate of SHR3824 and its metabolites in urine and feces, Accumulative excretion rate will be compared under fating state and fasted state, Day 1-4 on visit 2 and visit 3 | Secondary: The number of volunteers with adverse events as a measure of safety and tolerability., Up to Day 12 |
| Sponsor/Collaborators: | Sponsor: Jiangsu HengRui Medicine Co., Ltd. |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 12 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2014-05 |
| Completion Date: | 2014-09 |
| Results First Posted: | |
| Last Update Posted: | 2015-02-03 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT02353975 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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