TY - JOUR AU - SAPKAL, NIDHI AU - DAUD, ANWAR AU - BONDE, MINAL AU - GAWANDE, MANGESH AU - GURAV, NILAMBARI PY - 2021/09/07 Y2 - 2024/03/29 TI - BIOEQUIVALENCE EVALUATION OF ORALLY DISINTEGRATING STRIPS OF RIZATRIPTAN IN MALE VOLUNTEERS UNDER FASTING CONDITIONS JF - International Journal of Applied Pharmaceutics JA - Int J App Pharm VL - 13 IS - 5 SE - Original Article(s) DO - 10.22159/ijap.2021v13i5.41602 UR - https://journals.innovareacademics.in/index.php/ijap/article/view/41602 SP - 230-235 AB - <p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: 'Cambria','serif';">Objective: </span></strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: 'Cambria','serif';">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 Rizatriptan 10 mg, Maxalt-MLT® (reference) was conducted in 24 healthy male volunteers under fasting conditions. A single oral dose of 10 mg Rizatriptan was administrated to each volunteer.</span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: 'Cambria','serif';">Methods</span></strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: 'Cambria','serif';">: Plasma concentrations of Rizatriptan were determined by a validated LC-MS/MS bioanalytical method. The plasma concentrations of Rizatriptan were considered for statistical analysis and for establishing bioequivalence. Pharmacokinetic analysis was done by using the non-compartmental method. Pharmacokinetic parameters C<sub>max</sub>, AUC<sub>0→t</sub>, AUC <sub>0→∞</sub>, t<sub>1/2</sub>, T<sub>max, </sub>and Ke1 were estimated for each subject and each treatment.</span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: 'Cambria','serif';">Results: </span></strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: 'Cambria','serif';">Ninety percent confidence intervals (90% CI) calculated for the ratio of AUC<sub>0→t</sub>, AUC<sub>0→∞</sub>, and C<sub>max</sub> values for the test and reference formulations were 96.91-110.30%, 96.24-109.07%, and 90.37-113.56%, respectively for Rizatriptan. The 90% CIs of AUC<sub>0→t</sub>, AUC<sub>0→∞</sub>, and C<sub>max</sub> values were totally within 80-125%.</span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: 'Cambria','serif';">Conclusion: </span></strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: 'Cambria','serif';">Based on a statistical analysis of the results, both formulations of Rizatriptan 10 mg, were found to be bioequivalent in terms of rate and extent of absorption under fasting conditions.</span></p> ER -