This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal. The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
Combination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast
Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast
Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet
Unnamed facility
Beijing, Beijing Municipality, China
AUC0-t and Cmax (after repaglinide 2.0 mg and metformin 500 mg as co-administered tablets and combination tablet dosing under fed state)
Time frame: 24hr profile after single dose of trial drug in each treatment period
Repaglinide AUC(0-24 & 0-∞) and Cmax after combination tablet (repaglinide 1.0 mg/metformin 500 mg) during fed state
Time frame: 24hr profile after single dose of trial drug in each treatment period
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