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Clinical Trial Details

Trial ID: L4433
Source ID: NCT04334213
Associated Drug: Ckd-501
Title: A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150
Acronym: CKD-383
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: CKD-501|DRUG: D745, D150|DRUG: CKD-501, D745, D150
Outcome Measures: Primary: Cmax,ss of CKD-501, D745, D150, Cmax,ss: Maximum concentration of drug in plasma at steady state, Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours|AUCtau,ss of CKD-501, D745, D150, AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state, Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours | Secondary: Cmin,ss of CKD-501, D745, D150, Cmin,ss: Minimum concentration of drug in plasma at steady state, Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours|Tmax,ss of CKD-501, D745, D150, Tmax,ss: Time to maximum plasma concentration at steady state, Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours|CLss/F of CKD-501, D745, D150, CLss/F: Apparent Clearance at steady state, Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours|Fluctuation of CKD-501, D745, D150, Fluctuation: Peak trough fluctuation within one dosing interval, Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-05-07
Completion Date: 2020-08-05
Results First Posted:
Last Update Posted: 2020-10-30
Locations: Severance Hospital, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04334213