Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions
Abstract 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...
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Nature Portfolio
2025-07-01
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| Online Access: | https://doi.org/10.1038/s41598-025-04800-z |
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| author | Gökçe Sözer Muradiye Nacak Erol Durucu Wolfgang Martin Martin Reinsch Selma Koru Aydın Erenmemişoğlu |
| author_facet | Gökçe Sözer Muradiye Nacak Erol Durucu Wolfgang Martin Martin Reinsch Selma Koru Aydın Erenmemişoğlu |
| author_sort | Gökçe Sözer |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-583105881e884063a79700a33ff54975 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-583105881e884063a79700a33ff549752025-08-20T03:45:23ZengNature PortfolioScientific Reports2045-23222025-07-011511810.1038/s41598-025-04800-zBioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditionsGökçe Sözer0Muradiye Nacak1Erol Durucu2Wolfgang Martin3Martin Reinsch4Selma Koru5Aydın Erenmemişoğlu6Sanovel İlaç Sanayi ve Ticaret A.S.Gaziantep University Farmagen IKU Merkezi (Center for GCP)Gaziantep University Farmagen IKU Merkezi (Center for GCP)Pharmakin Consulting Services UGAnalytisches Zentrum Biopharm GmbHIDEAL Biyolojik Ürünler ve İlaç Danışmanlık Eğitim Ltd. Şti.Gaziantep University Farmagen IKU Merkezi (Center for GCP)Abstract 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.https://doi.org/10.1038/s41598-025-04800-zBioequivalencePharmacokineticsLurasidoneVariation |
| spellingShingle | Gökçe Sözer Muradiye Nacak Erol Durucu Wolfgang Martin Martin Reinsch Selma Koru Aydın Erenmemişoğlu Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions Scientific Reports Bioequivalence Pharmacokinetics Lurasidone Variation |
| title | Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions |
| title_full | Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions |
| title_fullStr | Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions |
| title_full_unstemmed | Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions |
| title_short | Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions |
| title_sort | bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions |
| topic | Bioequivalence Pharmacokinetics Lurasidone Variation |
| url | https://doi.org/10.1038/s41598-025-04800-z |
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