The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability of BCWP\_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to evaluate the food effect of Pharmacokinetic profile of BCWP\_C003 after administration.
Clinical Trials to Evaluate the Pharmacokinetic Profiles and Safety/Tolerability of BCWP\_C003 Formulation compared to Coadministration of Rosuvastatin and Metformin SR Formulation, and to Evaluate the Effect of Food on the Pharmacokinetic Profile of BCWP\_C003 after Single Oral Administration to Healthy Male Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
35
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
Participant will be administered a single oral dose of BCWP\_C003 under Fasting condition or Fed condition according to sequence.
Seoul National University Hospital
Seoul, South Korea
Rosuvastatin AUClast
Rosuvastatin AUClast
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin Cmax
Rosuvastatin Cmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Metformin AUClast
Metformin AUClast
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Metformin Cmax
Metformin Cmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
N-desmethyl rosuvastatin Cmax
N-desmethyl rosuvastatin Cmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
N-desmethyl rosuvastatin AUClast
N-desmethyl rosuvastatin AUClast
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
N-desmethyl rosuvastatin AUCinf
N-desmethyl rosuvastatin AUCinf
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf
Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf
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Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2
Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F
Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h