Evidence map›Paper›PMID 40595770›Full record

Trial reportScientific reports2025

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

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

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Gökçe SözerSanovel İlaç Sanayi ve Ticaret A.S., Esentepe Mahallesi, Bahar Sokak, Özdilek River Plaza Vyndham Grand No: 13/10, Şişli, İstanbul, Turkey. gokcesozer@sanovel.com.tr.ORCID http://orcid.org/0000-0002-4485-6316
Muradiye NacakGaziantep University Farmagen IKU Merkezi (Center for GCP), Gaziantep Üniversitesi Teknopark, Burç Yolu, 27200, Şahinbey, Gaziantep, Turkey.ORCID http://orcid.org/0000-0002-2651-4021
Erol DurucuGaziantep University Farmagen IKU Merkezi (Center for GCP), Gaziantep Üniversitesi Teknopark, Burç Yolu, 27200, Şahinbey, Gaziantep, Turkey.ORCID http://orcid.org/0000-0003-1685-5276
Wolfgang MartinPharmakin Consulting Services UG, Weidachstrasse 3/1, 89233, Neu-Ulm, Germany.ORCID https://orcid.org/0009-0004-0862-9396
Martin ReinschAnalytisches Zentrum Biopharm GmbH, Bitterfelder Strasse 19, 12681, Berlin, Germany.ORCID http://orcid.org/0009-0009-2643-1398
Selma KoruIDEAL Biyolojik Ürünler ve İlaç Danışmanlık Eğitim Ltd. Şti., Güvenevler Mahallesi İç sokak No:7/7, 06690, Çankaya, Ankara, Turkey.ORCID http://orcid.org/0009-0008-3959-9889
Aydın ErenmemişoğluGaziantep University Farmagen IKU Merkezi (Center for GCP), Gaziantep Üniversitesi Teknopark, Burç Yolu, 27200, Şahinbey, Gaziantep, Turkey.ORCID http://orcid.org/0000-0002-9277-1333

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 (AUC

Indexed as

Antipsychotic AgentsLurasidone HydrochlorideAdministration, OralAdultArea Under CurveChromatography, LiquidCross-Over StudiesFemaleHealthy VolunteersHumansMaleMiddle AgedTabletsTandem Mass SpectrometryTherapeutic EquivalencyYoung AdultAntipsychotic AgentsLurasidone HydrochlorideTabletsBioequivalenceLurasidonePharmacokineticsVariation

Identifiers

PMID40595770
PMCPMC12214960

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.