Clinical Trial Details
| Trial ID: | L5150 |
| Source ID: | NCT04317703 |
| Associated Drug: | Gemigliptin Tartrate Sesquihydrate And Metformin |
| Title: | Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Gemigliptin tartrate sesquihydrate and metformin|DRUG: gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release |
| Outcome Measures: | Primary: bioequivalence study, To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions, Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00, 32.00 and 48.00 hours post-dose | |
| Sponsor/Collaborators: | Sponsor: LG Chem |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 40 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2020-08-19 |
| Completion Date: | 2020-09-05 |
| Results First Posted: | |
| Last Update Posted: | 2021-02-09 |
| Locations: | International Bio Service Co., Ltd., Nakhon Pathom, Thailand |
| URL: | https://clinicaltrials.gov/show/NCT04317703 |
