BIOEQUIVALENCE EVALUATION OF ORALLY DISINTEGRATING STRIPS OF RIZATRIPTAN IN MALE VOLUNTEERS UNDER FASTING CONDITIONS

نویسندگان

چکیده

Objective: A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Rizatriptan 10 mg Orally Disintegrating Strips (ODS, test) with that of established Oral Lyophilisate mg, Maxalt-MLT® (reference) was conducted in 24 healthy male volunteers under fasting conditions. single oral dose administrated to each volunteer. Methods: Plasma concentrations were determined by a validated LC-MS/MS bioanalytical method. The plasma considered for statistical analysis and establishing bioequivalence. Pharmacokinetic done using the non-compartmental parameters Cmax, AUC0→t, AUC 0→∞, t1/2, Tmax, Ke1 estimated subject treatment. Results: Ninety percent confidence intervals (90% CI) calculated ratio AUC0→∞, Cmax values test reference formulations 96.91-110.30%, 96.24-109.07%, 90.37-113.56%, respectively Rizatriptan. 90% CIs totally within 80-125%. Conclusion: Based on results, both found be bioequivalent terms rate extent absorption

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ژورنال

عنوان ژورنال: International Journal of Applied Pharmaceutics

سال: 2021

ISSN: ['0975-7058']

DOI: https://doi.org/10.22159/ijap.2021v13i5.41602