Evidence map›Paper›PMID 32618438›Full record

Trial reportClinical pharmacology in drug development2021

The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers.

Mai Shibata, Junko Toyoshima, Yuichiro Kaneko, Kazuo Oda, Tsuyoshi Kiyota, Atsushi Kambayashi, Tetsuya Nishimura

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
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 at 2 institutions in 2 countries.

Mai ShibataAstellas Pharma Inc., Tokyo, Japan.
Junko ToyoshimaAstellas Pharma Inc., Tokyo, Japan.
Yuichiro KanekoAstellas Pharma Inc., Tokyo, Japan.
Kazuo OdaAstellas Research Institute of America LLC, Northbrook, Illinois, USA.
Tsuyoshi KiyotaAstellas Pharma Inc., Tokyo, Japan.
Atsushi KambayashiAstellas Pharma Inc., Tokyo, Japan.
Tetsuya NishimuraAstellas Pharma Inc., Tokyo, Japan.
Astellas Pharma (Japan) · JPAstellas Pharma (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The marketed tablet formulation of peficitinib differs from the tablet used during the clinical trials. The bioequivalence of the marketed formulation and developmental tablet, and the food effect on the marketed formulation, were analyzed in 2 Japanese open-label, randomized, 2-way crossover studies in healthy male volunteers. Volunteers received a single oral dose of the marketed 150-mg peficitinib tablet under fasted conditions (bioequivalence), and under fed or fasted conditions (food effect). Bioequivalence was compared with the developmental 150-mg tablet. Samples for pharmacokinetic analysis were collected before dose and ≤72 hours after dose. Safety assessments included adverse events, vital signs, and laboratory variables. In total, 40 and 18 subjects were randomized to the bioequivalence and food effect studies, respectively. The 2 peficitinib formulations were bioequivalent (90% confidence intervals of the geometric mean ratios for C

Indexed as

AdamantaneAdministration, OralAdultArea Under CurveArthritis, RheumatoidBiological AvailabilityCross-Over StudiesDose-Response Relationship, DrugDrug CompoundingDrug DevelopmentFastingFoodHealthy VolunteersHumansJanus Kinase InhibitorsJapanAdamantaneJanus Kinase InhibitorsNiacinamidepeficitinibbioequivalencefood effectJanus kinase inhibitorpeficitinibpharmacokinetics

Identifiers

PMID32618438
PMCPMC7984322
OpenAlexW3040004545

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.