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Clinical Trial Details

Trial ID: L6647
Source ID: NCT03849261
Associated Drug: Ckd-387
Title: Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 in Healthy Adults
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: CKD-387|DRUG: D635
Outcome Measures: Primary: Cmax of Dapagliflozin, Maximum plasma concentration of Dapagliflozin, 0 hour ~ 48 hour after drug administration|Cmax of Metformin, Maximum plasma concentration of Metformin, 0 hour ~ 48 hour after drug administration|AUClast of Dapagliflozin, Area under the plasma concentration-time curve to last concentration of Dapagliflozin, 0 hour ~ 48 hour after drug administration|AUClast of Metformin, Area under the plasma concentration-time curve to last concentration of Metformin, 0 hour ~ 48 hour after drug administration | Secondary: AUCinf of Dapagliflozin, Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin, 0 hour ~ 48 hour after drug administration|AUCinf of Metformin, Area under the plasma concentration-time curve from zero to infinity concentration of Metformin, 0 hour ~ 48 hour after drug administration|Tmax of Dapagliflozin, Time to maximum plasma concentration of Dapagliflozin, 0 hour ~ 48 hour after drug administration|Tmax of Metformin, Time to maximum plasma concentration of Metformin, 0 hour ~ 48 hour after drug administration|T1/2 of Dapagliflozin, Half-life of Dapagliflozin, 0 hour ~ 48 hour after drug administration|T1/2 of Metformin, Half-life of Metformin, 0 hour ~ 48 hour after drug administration|Vd/F of Dapagliflozin, Apparent volume of distribution of Dapagliflozin, 0 hour ~ 48 hour after drug administration|Vd/F of Metformin, Apparent volume of distribution of Metformin, 0 hour ~ 48 hour after drug administration|CL/F of Dapagliflozin, Apparent clearance of Dapagliflozin, 0 hour ~ 48 hour after drug administration|CL/F of Metformin, Apparent clearance of Metformin, 0 hour ~ 48 hour after drug administration
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-14
Completion Date: 2019-02-22
Results First Posted:
Last Update Posted: 2019-02-21
Locations: Severance Hospital, Seoul, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03849261