Bioequivalence Studies of Two Formulations of Baclofen Tablet in Healthy Volunteers
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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 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 25 mg.
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© 2022, Author(s). This open-access article is available under the Creative Commons Attribution 4.0 (CC BY 4.0) International License (https://creativecommons.org/licenses/by/4.0/), which allows for unrestricted use, distribution, and reproduction in any medium, provided that the original work is properly cited.
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