%0 Journal Article
%T Bioequivalence Studies of Two Formulations of Baclofen Tablet in Healthy Volunteers
%A Seyed Mohsen Foroutan
%A Alireza Shafaati
%A Afshin Zarghi
%A A Khoddam
%J Iranian Journal of Pharmaceutical Research
%D 2003
%I School of Pharmacy, Shahid Beheshti University of Medical Sciences
%X The relative bioavailability of the test (generic) product 2 ˇÁ 25 mg baclofen tablets, with respect to the reference product, Lioresal  2 ˇÁ 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 ˇ°test/referenceˇ± 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.
%K Baclofen tablet
%K Bioequivalence study
%K Plasma
%K AUC
%K Cmax
%U http://www.ijpr-online.com/Docs/20033/IJPR140.pdf