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Clinical Trial Details

Trial ID: L3453
Source ID: NCT04768673
Associated Drug: Ckd-393 Formulation I
Title: A Study to Investigate the PK and Safety of CKD-393
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type II Diabetes
Interventions: DRUG: CKD-393 formulation I|DRUG: CKD-393 formulation II|DRUG: D501, D759, H053
Outcome Measures: Primary: Cmax, Maximum concentration of drug in plasma, 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h|AUClast, Area under the plasma drug concentration-time curve to last concentration, 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h | Secondary: AUCinf, Area under the plasma drug concentration-time curve from 0 to infinity, 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h|Tmax, Time to maximum plasma concentration, 0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h|t1/2, Terminal elimination half-life, 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h|Vd/F, Apparent Volume of Distribution, 0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h|CL/F, Apparent Clearance, 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-26
Completion Date: 2021-04-27
Results First Posted:
Last Update Posted: 2021-08-02
Locations: Severance Hospital, Seoul, Seodaemun-gu,, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04768673

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress