This study was designed to compare the bioavailability of the Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fed conditions.
An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of Single Doses of Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in Healthy, Adult Male and Female Subjects Under Fed Conditions. During each period 21 blood samples were taken: prior to dosing (-1.0) and 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 16.0, 24.0, 32.0 and 36.0 hours after IMP administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
One tablet of the Test (T) product was administered orally with 240 mL of water.
One tablet of the Reference (R) product was administered orally with 240 mL of water.
QUINTA-ANALYTICA s.r.o.
Prague, Czechia
Cmax
maximum plasma concentration observed (Cmax)
Time frame: up to 36 hours post-administration
AUC0-t
Area under the plasma concentration versus time curve calculated by the trapezoidal rule from sampling time zero to sampling time of the last measurable plasma concentration (AUC0-t)
Time frame: up to 36 hours post-administration
AUC0-∞
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞)
Time frame: up to 36 hours post-administration
tmax
The time of the maximum plasma concentration (tmax).
Time frame: up to 36 hours post-administration
λz
Apparent first-order elimination (λz)
Time frame: up to 36 hours post-administration
t1/2
the elimination or terminal half-life (t1/2)
Time frame: up to 36 hours post-administration
AUCres
Residual area AUCres = 100 (AUC0-∞ - AUC0-t) / AUC0-∞ \[%\]
Time frame: up to 36 hours post-administration
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