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Clinical Trial Details

Trial ID: L3963
Source ID: NCT04223895
Associated Drug: Ckd-386 Formulation 1
Title: A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Adult Volunteers
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: CKD-386 Formulation 1|DRUG: CKD-386 Formulation 2|DRUG: D012, D326 and D337
Outcome Measures: Primary: AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337, AUCt: Area under the concentration-time curve, 0(predose)~72 hours|Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337, Cmax: Maximum plasma concentration of the drug, 0(predose)~72 hours | Secondary: AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337, AUCinf: Area under the concentration-time curve from zero up to ∞, 0(predose)~72 hours|tmax each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337, tmax: Time to maximum plasma concentration, 0(predose)~72 hours|AUCt/AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337, AUCt/AUCinf: AUCt/AUCinf Ratio, 0(predose)~72 hours|t1/2 each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337, t1/2: Terminal elimination half-life, 0(predose)~72 hours|AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337, AUCt: Area under the concentration-time curve, 0(predose)~72 hours|Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337, Cmax: Maximum plasma concentration of the drug, 0(predose)~72 hours
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-02-01
Completion Date: 2020-06-15
Results First Posted:
Last Update Posted: 2020-01-10
Locations:
URL: https://clinicaltrials.gov/show/NCT04223895