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Clinical Trial Details

Trial ID: L2031
Source ID: NCT04810676
Associated Drug: Ckd-501, D745, D150
Title: A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: CKD-501, D745, D150|DRUG: CKD-383
Outcome Measures: Primary: AUClast of CKD-383, AUClast: Area under the concentration-time curve from time zero to the last measurable concetnration time, 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)|Cmax of CKD-383, Cmax: Maximum plasma concentration of the drug, 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours) | Secondary: AUCinf of CKD-383, AUCinf: Area under the concentration-time curve from zero up to infinity, 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)|Tmax of CKD-383, Tmax: Time to maximum plasma concentration, 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)|T1/2 of CKD-383, T1/2: Terminal elimination half-life, 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)|Vd/F of CKD-383, Vd/F: Volume of distribution, 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)|CL/F of CKD-383, CL/F: Clearance, 0(pre-dose), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, 48(hours)
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-04-16
Completion Date: 2021-05-26
Results First Posted:
Last Update Posted: 2021-06-10
Locations: Severance Hospital, Seoul, Yonsei-ro, Seodaemun-gu 50-1, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04810676

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress