This was an open-label, randomized, fed, single-dose, 2-sequence, 2- period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" in healthy adult volunteers.
A total of 40 healthy volunteers will be enrolled to evaluate the pharmacokinetics and safety profiles of the study drug (one combination tablet of dapagliflozin 10 mg/pioglitazone 30 mg/metformin HCl 1000 mg) and the comparator (co-administration of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg, one tablet each, respectively) while fed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Orally administered once per day
Orally administered once per day
Orally administered once per day
H Plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
RECRUITINGPharmacokinetic variable - AUCt
Area under the drug concentration-time curve over the time interval of "BR3006"
Time frame: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
Pharmacokinetic variable - Cmax
Maximum plasma concentration of "BR3006"
Time frame: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
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Orally administered once per day