The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence. The test product, Reumoxicam® 15 mg tablets (Farmak PJSC, Ukraine), given in a single dose was compared with a licensed reference product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece), in a randomized, laboratory-blind, single dose, two periods, crossover study. The secondary objective of the trial was to investigate the safety of both preparations on the basis of safety clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/ or adverse drug reactions.
Randomized, single-dose, crossover, two-period, two-sequence, laboratory-blinded, comparative bioavailability study of test medicinal product Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine) and reference medicinal product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece) in healthy volunteers under fasting condition. During each period 18 blood samples were taken: before dosing (0) and then at: 0.5; 1; 2; 3; 4; 4.5; 5; 5.5; 6; 7; 8; 10; 12; 24; 36; 48 and 72 hours after dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
One tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.
One tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.
AUC0-t
Area under the plasma concentration-time curve from time zero to time t of the last quantifiable concentration
Time frame: up to 72 hours post-administration
Cmax
Maximum drug concentration in plasma
Time frame: up to 72 hours post-administration
AUC0-inf
Area under the plasma concentration-time curve from time zero to infinity
Time frame: up to 72 hours post-administration
tmax
time after administration to reach maximum drug concentration in plasma
Time frame: up to 72 hours post-administration
t1/2
elimination half-life
Time frame: up to 72 hours post-administration
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