The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
120
Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose
dapagliflozin tablet 2.5 mg Oral Single dose
metformin IR tablet 850 mg Oral Single dose
Research Site
Berlin, Germany
bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.
Time frame: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.
To examine the safety and tolerability of the combination of dapagliflozin and metformin.
Time frame: Throughout study (for 4 days in each period and a follow-up visit ~6 days later)
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Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose
dapagliflozin tablet 5 mg Oral Single dose
metformin IR tablet 1000 mg Oral Single dose