Abstract
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 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. Methods: 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 Cmax, AUC0→t, AUC 0→∞, t1/2, Tmax, and Ke1 were estimated for each subject and each treatment. Results: Ninety percent confidence intervals (90% CI) calculated for the ratio of AUC0→t, AUC0→∞, and Cmax 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 AUC0→t, AUC0→∞, and Cmax values were totally within 80-125%. Conclusion: 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.
Highlights
Migraine is a common neurologic disorder with a paroxysmal character
For Rizatriptan, the geometric mean and 90% confidence interval based on least-squares mean obtained from ANOVA for the pharmacokinetic parameters Cmax, AUC0→t, and AUC0→∞ are summarized in table 3
This study indicated that Cmax, AUC0→∞, and AUC0→t was comparable for the Orally disintegrating strip (ODS) and Maxalt-MLT formulations
Summary
Migraine is a common neurologic disorder with a paroxysmal character. Lost work productivity following migraine attacks severely affects both patients and society. This condition is most prevalent during the most economically productive years of the person, with a peak at ~ 40 y of age. Migraine attacks can lead to disabilities and affect the quality of relationships, social behavior, economic assets, emotional well-being, and overall health of the patients [6,7,8]. Effective treatment of acute migraine attacks is always looked for in clinical practices for improving health-related quality of life and economic growth [9]
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