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Clinical Trial Details

Trial ID: L4395
Source ID: NCT03738449
Associated Drug: Ckd-387
Title: The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: CKD-387|DRUG: D484
Outcome Measures: Primary: Maximum plasma concentration of Metformin, Cmax of Metformin, 0 hour ~ 48 hour after drug administration|Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration, AUClast of Metformin, 0 hour ~ 48 hour after drug administration | Secondary: Area under the plasma concentration of Metformin-time curve from time zero to infinity, AUCinf of Metformin, 0 hour ~ 48 hour after drug administration|Time to reach maximum (peak) plasma concentration of Metformin following drug administration, Tmax of Metformin, 0 hour ~ 48 hour after drug administration|Half-life of Metformin, t1/2 of Metformin, 0 hour ~ 48 hour after drug administration|Apparent clearance of Metformin, CL/F of Metformin, 0 hour ~ 48 hour after drug administration|Apparent volume of distribution of Metformin, Vd/F of Metformin, 0 hour ~ 48 hour after drug administration
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 23
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-08
Completion Date: 2019-01-24
Results First Posted:
Last Update Posted: 2019-02-21
Locations: Severance Hospital, Seoul, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03738449