BIOEQUIVALENCE STUDIES OF TWO FORMULATIONS OF BACLOFEN TABLET IN HEALTHY VOLUNTEERS

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FOROUTAN S.M.; SHAFAATI A.R.; ZARGHI A.; KHODAM A.

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Journal Paper

Paper Information

Journal: Iranian Journal of Pharmaceutical Research Year:2003 | Volume:2 | Issue:3 Page(s): 153-155

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Information Journal Paper

Title

BIOEQUIVALENCE STUDIES OF TWO FORMULATIONS OF BACLOFEN TABLET IN HEALTHY VOLUNTEERS

Author(s)

FOROUTAN S.M. | SHAFAATI A.R. | ZARGHI A. | KHODAM A. | Issue Writer Certificate

Keywords

BACLOFEN TABLET

BIOEQUIVALENCE STUDY

PLASMA

AUC

CMAX

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.

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APA: Copy

FOROUTAN, S.M., SHAFAATI, A.R., ZARGHI, A., & KHODAM, A.. (2003). BIOEQUIVALENCE STUDIES OF TWO FORMULATIONS OF BACLOFEN TABLET IN HEALTHY VOLUNTEERS. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 2(3), 153-155. SID. https://sid.ir/paper/286963/en

Vancouver: Copy

FOROUTAN S.M., SHAFAATI A.R., ZARGHI A., KHODAM A.. BIOEQUIVALENCE STUDIES OF TWO FORMULATIONS OF BACLOFEN TABLET IN HEALTHY VOLUNTEERS. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2003;2(3):153-155. Available from: https://sid.ir/paper/286963/en

IEEE: Copy

S.M. FOROUTAN, A.R. SHAFAATI, A. ZARGHI, and A. KHODAM, “BIOEQUIVALENCE STUDIES OF TWO FORMULATIONS OF BACLOFEN TABLET IN HEALTHY VOLUNTEERS,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 2, no. 3, pp. 153–155, 2003, [Online]. Available: https://sid.ir/paper/286963/en

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