Author/Authors :
Foroutan, Mohsen Noor Research and Educational Institute, Tehran , Shafaati, Alireza Pharmaceutical Sciences Research Center, School of Pharmacy, Shaheed Beheshti University of Medical Sciences, Tehran , Zarghi, Afshin Pharmaceutical Sciences Research Center, School of Pharmacy, Shaheed Beheshti University of Medical Sciences, Tehran , Khoddam, A Pharmaceutical Sciences Research Center, School of Pharmacy, Shaheed Beheshti University of Medical Sciences, Tehran
Abstract :
The relative bioavailability of the test (generic) product 2 × 25 mg baclofen tablets, with respect
to the reference product, Lioresal® 2 × 25 mg tablets (baclofen; Squibb) was determined in a singleblind,
single dose, randomised, crossover study. The mean values for the variable Cmax were
737.6 ng/ml for the reference and 739.5 ng/ml for the test product. The mean values for the variable
AUC were 3980.3 hr.ng/ml and 4066.7 ng.hr/ml for the reference and test, respectively. The 90%
confidence intervals for the “test/reference” mean ratios of the plasma baclofen pharmacokinetic
variables Cmax and AUC0-t (as measures of the rate and extent of absorption of baclofen,
respectively) lie between 0.98 and 1.06, which is within the conventional bioequivalence range of
80-125%. The test product (baclofen) is therefore bioequivalent to the reference product (Lioresal®)
with respect to the rate and the extent of absorption of baclofen with a strength of 25 mg
Keywords :
Baclofen tablet , Bioequivalence study , Plasma , AUC , Cmax
