Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3007
Source ID: NCT03849339
Associated Drug: Ckd-387
Title: Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 Under Fed Condition
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: CKD-387|DRUG: D635
Outcome Measures: Primary: Cmax of Metformin, Maximum plasma concentration of Metformin, 0 hour ~ 48 hour after drug administration|AUClast of Metformin, Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration, 0 hour ~ 48 hour after drug administration | Secondary: AUCinf of Metformin, Area under the plasma concentration of Metformin-time curve from time zero to infinity, 0 hour ~ 48 hour after drug administration|Tmax of Metformin, Time to reach maximum (peak) plasma concentration of Metformin following drug administration, 0 hour ~ 48 hour after drug administration|t1/2 of Metformin, Half-life of Metformin, 0 hour ~ 48 hour after drug administration|CL/F of Metformin, Apparent clearance of Metformin, 0 hour ~ 48 hour after drug administration|Vd/F of Metformin, Apparent volume of distribution of Metformin, 0 hour ~ 48 hour after drug administration
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-28
Completion Date: 2019-02-28
Results First Posted:
Last Update Posted: 2019-02-21
Locations: Severance Hospital, Seoul, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03849339