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Clinical Trial Details

Trial ID: L5605
Source ID: NCT04156685
Associated Drug: Part A, Reference (D635 10/500mg, Astrazeneca)
Title: Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Part A, Reference (D635 10/500mg, Astrazeneca)|DRUG: Part A, Reference (D635 10/500mg, Astrazeneca)|DRUG: Part B, Reference (D635 10/500mg, Astrazeneca)|DRUG: Part B, Reference (D635 10/500mg, Astrazeneca)
Outcome Measures: Primary: Part A : Cmax under fasting condition, Maximum concentration of the dapagliflozin, 0(predose)~48 hours|Part A : Cmax under fasting condition, Maximum concentration of the metformin, 0(predose)~48 hours|Part A : AUClast under fasting condition, Area Under Curve(last) of the dapagliflozin, 0(predose)~48 hours|Part A : AUClast under fasting condition, Area Under Curve(last) of the metformin, 0(predose)~48 hours|Part B : Cmax under fed condition, Maximum concentration of the metformin, 0(predose)~48 hours|Part B : AUClast under fed condition, Area Under Curve(last) of the metformin, 0(predose)~48 hours | Secondary: Part A : AUCinf under fasting condition, Area Under Curve(infinit) of the dapagliflozin, 0(predose)~48 hours|Part A : AUCinf under fasting condition, Area Under Curve(infinit) of the metformin, 0(predose)~48 hours|Part A : Tmax under fasting condition, Time of maximum concentration of the dapagliflozin, 0(predose)~48 hours|Part A : Tmax under fasting condition, Time of maximum concentration of the metformin, 0(predose)~48 hours|Part A : t1/2 under fasting condition, Half life of the dapagliflozin, 0(predose)~48 hours|Part A : t1/2 under fasting condition, Half life of the metformin, 0(predose)~48 hours|Part B : AUCinf under fed condition, Area Under Curve(infinit) of the metformin, 0(predose)~48 hours|Part B : Tmax under fed condition, Time of Maximum concentration of the metformin, 0(predose)~48 hours|Part B : t1/2 under fed condition, Half life of the metformin, 0(predose)~48 hours
Sponsor/Collaborators: Sponsor: Chong Kun Dang Pharmaceutical
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 58
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2019-08-06
Completion Date: 2019-10-02
Results First Posted:
Last Update Posted: 2019-11-07
Locations: Korea University Anam Hospital, Seoul, Seongbuk-Gu, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04156685