The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
1 Tramadol Contramid OAD 200 mg tablet as a single dose
1 Zytram 200 mg tablet as a single dose
AUC(0-t)
Area under the plasma concentration versus time curve to the last measured concentration. h=hour
Time frame: 48 hours
AUC (0-∞)
The area under the plasma concentration curve was estimated by extrapolating to infinity AUC0-t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R'2 (coefficient of determination). The units are ng.h/mL. h=hours
Time frame: 48 hours
Cmax
Maximum plasma concentration
Time frame: 48 hours
t1/2
Apparent terminal elimination half-life
Time frame: 48 hours
Tmax
Time to maximum plasma concentration
Time frame: 48 hours
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