To perform a comparative evaluation on the pharmacokinetics and the safety after administration of "BR3003" and co-administration of "BR3003B" and "BR3003C" in healthy adults.
A randomized, open-label, single oral dose, two-way crossover study under fasting condition. Target number of subjects: 46 subjects in total.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Test drug (T):"BR3003" Boryung Pharmaceutical Co., Ltd.
Reference drug 1 (R1): "BR3003B" of Celltrion Pharm, Inc.
Reference drug 2 (R2): "BR3003C" of AstraZeneca Korea
Clinical Research Center, H PLUS Yangji Hospital
Seoul, Gwanakgu, South Korea
Pharmacokinetic variables - AUC
Area under the plasma concentration versus time curve(AUCt) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.)
Time frame: Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Cmax
Peak Plasma Concentration(Cmax) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.)
Time frame: Pre-dose(0hour), 0.167hour(10 min), 0.333hour(20 min), 0.5hour(30 minutes), 0.667hour(40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUC∞
AUC∞ of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for each Period.)
Time frame: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt/AUC∞
AUCt/AUC∞ of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for each Period.)
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Tmax
Tmax of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for eachour Period.)
Time frame: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
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Pharmacokinetic variables - t1/2
t1/2 of Pioglitazone and Dapagliflozin (Blood samples are collected 22 times for eachour Period.)
Time frame: Pre-dose (0hour), 0.167hour (10min), 0.333hour (20 min), 0.5hour (30 min), 0.667hour (40min), 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt of Pioglitazone M-IV
AUCt of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Cmax of Pioglitazone M-IV
Cmax of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUC∞ of Pioglitazone M-IV
AUC∞ of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - AUCt/AUC∞ of Pioglitazone M-IV
AUCt/AUC∞ of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - Tmax of Pioglitazone M-IV
Tmax of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour
Pharmacokinetic variables - t1/2 of Pioglitazone M-IV
t1/2 of Pioglitazone M-IV (Blood samples are collected 14 times for eachour Period.)
Time frame: Pre-dose (0hour), 2hour, 4hour, 6hour, 8hour, 10hour, 12hour, 14hour, 16hour, 18hour, 24hour, 48hour, 72hour, 96hour