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Clinical Trial Details

Trial ID: L1875
Source ID: NCT04221360
Associated Drug: Ckd-375
Title: A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: CKD-375|DRUG: D390
Outcome Measures: Primary: Cmax of D390 and CKD-375, Maximum plasma concentration of D390 and CKD-375, 0(predose)~48 hours|AUClast of D390 and CKD-375, Area under the plasma concentration-time curve to last concentration of D390 and CKD-375, 0(predose)~48 hours | Secondary: AUCinf of D390 and CKD-375, Area under the plasma concentration-time curve from zero to infinity concentration of D390 and CKD-375, 0(predose)~48 hours|Tmax of D390 and CKD-375, Time to maximum plasma concentration of D390 and CKD-375, 0(predose)~48 hours|t1/2 of D390 and CKD-375, Half-life of D390 and CKD-375, 0(predose)~48 hours|Vd/F of D390 and CKD-375, Apparent volume of distribution of D390 and CKD-375, 0(predose)~48 hours|CL/F of D390 and CKD-375, Apparent clearance of D390 and CKD-375, 0(predose)~48 hours
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: 2020-01-29
Completion Date: 2020-06-08
Results First Posted:
Last Update Posted: 2020-01-09
Locations: Yonsei University Severance Hospital, Soeul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04221360