Evidence mapPaperPMID 35315257Full record

Trial reportClinical pharmacology in drug development2022

Bioequivalence of Esaxerenone Conventional Tablet and Orally Disintegrating Tablet: Two Single-Dose Crossover Studies in Healthy Japanese Men.

Akifumi Kurata, Takashi Eto, Junko Tsutsumi, Yoshiyuki Igawa, Yasuhiro Nishikawa, Hitoshi Ishizuka

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 53% of its field
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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
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

6 authors at 2 institutions in 2 countries.

Akifumi KurataQuantitative Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Takashi EtoSouseikai Hakata Clinic, Fukuoka, Japan.
Junko TsutsumiData Intelligence Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Yoshiyuki IgawaQuantitative Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Yasuhiro NishikawaDevelopment Strategy & Planning Group, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Hitoshi IshizukaQuantitative Clinical Pharmacology Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Daiichi-Sankyo (Japan) · JPSOUSEIKAI Global Clinical Research Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We assessed the bioequivalence of a single dose of 5-mg of esaxerenone administered as an orally disintegrating tablet (ODT) with the conventional oral tablet in healthy Japanese men. This single-center, open-label, randomized, two-drug, two-stage crossover, single-dose study was conducted in two parts. In study 1, both formulations were taken with water. In study 2, only the ODT formulation was taken without water. The primary outcome was the evaluation of bioequivalence of the ODT and conventional tablet using the pharmacokinetic (PK) parameters maximum plasma concentration (C

Indexed as

WaterAdministration, OralCross-Over StudiesHumansJapanMalePyrrolesSulfonesTabletsTherapeutic EquivalencyesaxerenonePyrrolesSulfonesTabletsWaterbioequivalenceesaxerenone (CS-3150)hypertensionmineralocorticoid receptor blockerorally disintegrating tablets

Identifiers

PMID35315257
PMCPMC9545664
OpenAlexW4221114053

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.