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<p>To define the bioequivalence (BE) of two orally administered film coated tablets containing 40&#xa0;mg lurasidone hydrochloride. A single-dose, open-label, randomized two-way crossover trial was conducted under fed conditions, with a washout period of at least one week. Blood samples were drawn over a period of 72&#xa0;h and plasma concentrations were analysed using a Liquid Chromatography tandem Mass Spectrometry (LC–MS/MS) method. The Pharmacokinetic (PK) parameters were calculated using Phoenix WinNonlin software, based on non-compartmental analysis. The two one-sided hypothesis at the α = 0.05 level of significance was tested by constructing the 90% confidence interval of two one-sided t-tests for the geometric mean ratios test versus reference preparation with analysis of variance (ANOVA). After oral administration of 40&#xa0;mg lurasidone hydrochloride under fed conditions, the mean area under the curve (AUC<sub>t</sub>, AUC<sub>∞</sub>) and maximum plasma concentrations (C<sub>max</sub>) were 175&#xa0;ng/mL*h; 184&#xa0;ng/mL*h and 60&#xa0;ng/mL, respectively for the test product and 185&#xa0;ng/mL*h; 198&#xa0;ng/mL*h and 59&#xa0;ng/mL respectively for the reference product. 90% Confidence Intervals (CI) for all PK parameters were within the acceptance range of 80.00–125.00%. BE was demonstrated between the generic product and the innovator product in healthy Caucasian male subjects. No clinically meaningful differences in safety or tolerability were observed.</p>

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Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月1日

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  • Gökçe Sözer,
  • Muradiye Nacak,
  • Erol Durucu,
  • Wolfgang Martin,
  • Martin Reinsch,
  • Selma Koru,
  • Aydın Erenmemişoğlu

摘要

To define the bioequivalence (BE) of two orally administered film coated tablets containing 40 mg lurasidone hydrochloride. A single-dose, open-label, randomized two-way crossover trial was conducted under fed conditions, with a washout period of at least one week. Blood samples were drawn over a period of 72 h and plasma concentrations were analysed using a Liquid Chromatography tandem Mass Spectrometry (LC–MS/MS) method. The Pharmacokinetic (PK) parameters were calculated using Phoenix WinNonlin software, based on non-compartmental analysis. The two one-sided hypothesis at the α = 0.05 level of significance was tested by constructing the 90% confidence interval of two one-sided t-tests for the geometric mean ratios test versus reference preparation with analysis of variance (ANOVA). After oral administration of 40 mg lurasidone hydrochloride under fed conditions, the mean area under the curve (AUCt, AUC∞) and maximum plasma concentrations (Cmax) were 175 ng/mL*h; 184 ng/mL*h and 60 ng/mL, respectively for the test product and 185 ng/mL*h; 198 ng/mL*h and 59 ng/mL respectively for the reference product. 90% Confidence Intervals (CI) for all PK parameters were within the acceptance range of 80.00–125.00%. BE was demonstrated between the generic product and the innovator product in healthy Caucasian male subjects. No clinically meaningful differences in safety or tolerability were observed.