Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5290
Source ID: NCT03646799
Associated Drug: Ckd-387
Title: Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type II Diabetes
Interventions: DRUG: CKD-387|DRUG: D484
Outcome Measures: Primary: Cmax of Dapagliflozin, Maximum plasma concentration of Dapagliflozin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|Cmax of Metformin, Maximum plasma concentration of Metformin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|AUClast of Dapagliflozin, Area under the plasma concentration-time curve to last concentration of Dapagliflozin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|AUClast of Metformin, Area under the plasma concentration-time curve to last concentration of Metformin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration | Secondary: AUCinf of Dapagliflozin, Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|AUCinf of Metformin, Area under the plasma concentration-time curve from zero to infinity concentration of Metformin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|Tmax of Dapagliflozin, Time to maximum plasma concentration of Dapagliflozin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|Tmax of Metformin, Time to maximum plasma concentration of Metformin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|T1/2 of Dapagliflozin, Half-life of Dapagliflozin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|T1/2 of Metformin, Half-life of Metformin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|Vd/F of Dapagliflozin, Apparent volume of distribution of Dapagliflozin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|Vd/F of Metformin, Apparent volume of distribution of Metformin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|CL/F of Dapagliflozin, Apparent clearance of Dapagliflozin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration|CL/F of Metformin, Apparent clearance of Metformin, Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 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: 2018-08-30
Completion Date: 2018-09-14
Results First Posted:
Last Update Posted: 2018-08-24
Locations: Yonsei University Severance Hospital, Soeul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03646799

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress