Bioequivalence Studies of Two Formulations of Baclofen Tablet in Healthy Volunteers
| Author | Seyed Mohsen Foroutan | en |
| Author | Alireza Shafaati | en |
| Author | Afshin Zarghi | en |
| Author | A Khoddam | en |
| Issued Date | 2003-07-31 | en |
| 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. | en |
| DOI | https://doi.org/10.22037/ijpr.2010.52 | en |
| Keyword | Cmax | en |
| Keyword | AUC | en |
| Keyword | Plasma | en |
| Keyword | Bioequivalence study | en |
| Keyword | Baclofen tablet | en |
| Publisher | Brieflands | en |
| Title | Bioequivalence Studies of Two Formulations of Baclofen Tablet in Healthy Volunteers | en |
| Type | Research Article | en |
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