Clinical Trial Details
| Trial ID: | L5739 |
| Source ID: | NCT03864432 |
| Associated Drug: | Gemigliptin 25mg |
| Title: | An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Gemigliptin 25mg|DRUG: Gemigliptin 50mg|DRUG: Gemigliptin 100mg|DRUG: Gemiglptin 50mg multiple dose |
| Outcome Measures: | Primary: AUClast of Gemigliptin, 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h|Cmax of Gemigliptin, 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h | |
| Sponsor/Collaborators: | Sponsor: LG Chem |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 48 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2019-07-02 |
| Completion Date: | 2020-02-28 |
| Results First Posted: | |
| Last Update Posted: | 2020-03-03 |
| Locations: | Shanghai Xuhui Central hospital, Shanghai, 200002, China |
| URL: | https://clinicaltrials.gov/show/NCT03864432 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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