This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under non-fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
40
1 x 5 mg/500 mg, single-dose non-fasting
1 x 5 mg/500 mg, single-dose non-fasting
PRACS Institute Ltd.
East Grand Forks, Minnesota, United States
PRACS Institute, Ltd.
Fargo, North Dakota, United States
Cmax (Maximum Observed Concentration) - Glipizide in Plasma
Bioequivalence based on Cmax
Time frame: Blood samples collected over 36 hour period
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glipizide
Bioequivalence based on AUC0-inf
Time frame: Blood samples collected over 36 hour period
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 36 hour period
Cmax (Maximum Observed Concentration) - Metformin in Plasma
Bioequivalence based on Cmax
Time frame: Blood samples collected over 36 hour period
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin
Bioequivalence based on AUC0-inf
Time frame: Blood samples collected over 36 hour period
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 36 hour period
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