Evidence map›Paper›PMID 32302056›Full record

Trial reportPharmacology research & perspectives2020

Relative bioavailability of a pediatric dispersible tablet and adult film-coated tablet of macitentan in healthy volunteers.

Patricia N Sidharta, Radka Štěpánová, Susanne Globig, Ivan Ulč, Dénes Csonka

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Pharmacology research & perspectives, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 23% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. 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

5 authors at 3 institutions in 2 countries.

Patricia N SidhartaIdorsia Pharmaceuticals Ltd., Allschwil, Switzerland.
Radka ŠtěpánováAixial s.r.o., Brno, Czech Republic.
Susanne GlobigIdorsia Pharmaceuticals Ltd., Allschwil, Switzerland.
Ivan UlčCEPHA s.r.o., Plzeň, Czech Republic.
Dénes CsonkaActelion Pharmaceuticals Ltd., Allschwil, Switzerland.ORCID 0000-0001-7797-2615
Idorsia (Switzerland) · CHActelion (Switzerland) · CHKomix (Czechia) · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To compare the pharmacokinetic (PK) properties of the pediatric dispersible tablet formulation of macitentan and the adult film-coated tablet formulation of macitentan in healthy subjects. A randomized, open-label, single-dose, two-sequence, two-period, crossover, Phase 1 study was conducted in 12 healthy adults. Subjects were randomized to one of the two possible treatment sequences A/B or B/A on Day 1 under fasted conditions. Treatment A was a single 10 mg dose of macitentan (film-coated adult formulation) and Treatment B was a single 10 mg dose of macitentan, consisting of two 5 mg dispersible tablets (pediatric formulation). PK sampling over 216 hours was conducted, and PK parameters were derived using non-compartmental methods. For macitentan, geometric means ratio of peak plasma concentrations (C

Indexed as

AdolescentAdultArea Under CurveBiological AvailabilityChildCross-Over StudiesFastingHealthy VolunteersHumansMalePyrimidinesSulfonamidesTabletsYoung AdultmacitentanPyrimidinesSulfonamidesTabletsbioavailabilityclinical trialspediatricsrespiratory medicine

Identifiers

PMID32302056
PMCPMC7164404
OpenAlexW3016557461

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.