Clinical Trial Details
| Trial ID: | L6645 |
| Source ID: | NCT02167061 |
| Associated Drug: | Da-1229_01 |
| Title: | A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: DA-1229_01|DRUG: E+M|DRUG: DA-1229_01 fast|DRUG: DA-1229_01 fed |
| Outcome Measures: | Primary: Area Under Curve(AUC)last of Evogliptin and Metformin, 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose|Maximum of concentration (Cmax) of Evogliptin and Metformin, 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose | Secondary: Time of maximum concentration(Tmax) of Evogliptin and Metformin, 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose|Terminal half-life(t1/2) of Evogliptin and Metformin, 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose|Apparent Clearance(CL/F) of Evogliptin and Metformin, 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose|Area Under Curve(AUC)inf of Evogliptin and Metformin, AUCinf = AUC last + Clast/λz, 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose|Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial), 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose |
| Sponsor/Collaborators: | Sponsor: Dong-A ST Co., Ltd. |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 64 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2014-07 |
| Completion Date: | 2014-11 |
| Results First Posted: | |
| Last Update Posted: | 2014-12-02 |
| Locations: | Clinical Trial Center, Seoul National University Hospital, Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT02167061 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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