Paper Information

Journal:   IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)   Summer 2003 , Volume 2 , Number 3; Page(s) 153 To 155.
 
Paper: 

BIOEQUIVALENCE STUDIES OF TWO FORMULATIONS OF BACLOFEN TABLET IN HEALTHY VOLUNTEERS

 
 
Author(s):  FOROUTAN S.M.*, SHAFAATI A.R., ZARGHI A., KHODAM A.
 
* NOOR RESEARCH AND EDUCATIONAL INSTITUTE, TEHRAN, IRAN
 
Abstract: 

The relative bioavailability of the test (generic) product 2×25mg baclofen tablets, with respect to the reference product, Lioresal® 2×25mg tablets (baclofen; Squibb) was determined in a single-blind, 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 25mg.

 
Keyword(s): BACLOFEN TABLET, BIOEQUIVALENCE STUDY, PLASMA, AUC, CMAX
 
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