Evidence mapPaperPMID 38764241Full record

Trial reportPharmacology research & perspectives2024

Bioequivalence and the food effect of macitentan/tadalafil 10/20 fixed-dose combination tablets versus the use of single-component tablets in healthy subjects.

Jennifer Lynn Ford, Ahad Sabet, Jaya Natarajan, Hans Stieltjes, Daniel L Chao, Navin Goyal, Denes Csonka

Abstract readRandomized Controlled TrialClinical Trial, Phase IComparative Study
In one paragraph

Trial report in Pharmacology research & perspectives, 2024. 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
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

3 citing papers in PubMed.

  1. Trial
  2. Update on pulmonary hypertension.Respiratory research · 2026
    Review
  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.

Jennifer Lynn FordJanssen Research & Development, Spring House, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-1740-5704
Ahad SabetICON, Salt Lake City, Utah, USA.ORCID https://orcid.org/0009-0004-7266-3310
Jaya NatarajanJanssen Research & Development, Raritan, New Jersey, USA.ORCID https://orcid.org/0009-0009-4833-1750
Hans StieltjesJanssen Research & Development, Beerse, Belgium.ORCID https://orcid.org/0009-0006-6913-7285
Daniel L ChaoJanssen Research & Development, Raritan, New Jersey, USA.ORCID https://orcid.org/0000-0001-9174-8118
Navin GoyalJanssen Research & Development, Raritan, New Jersey, USA.ORCID https://orcid.org/0000-0002-8521-0108
Denes CsonkaActelion Pharmaceuticals, A Janssen Pharmaceutical Company of Johnson & Johnson, Allschwil, Switzerland.ORCID https://orcid.org/0000-0001-7797-2615

Funding

Janssen Research and Development
6 · The paper itself

Abstract

The primary aim was to demonstrate bioequivalence between the 10/20 mg fixed-dose combination (FDC) of macitentan/tadalafil in a single tablet and the free combination of both drugs, and to evaluate the food effect on the 10/20 mg FDC in healthy participants. In this single-center, randomized, open-label, 3-way crossover, single-dose Phase 1 study in healthy adult participants, macitentan/tadalafil was administered as a 10/20 mg FDC formulation and compared with the free combination of macitentan and tadalafil. The food effect on the FDC was also evaluated. Pharmacokinetic sampling (216 h) was conducted. The 90% confidence intervals (CIs) for the geometric mean ratios of maximum observed plasma analyte concentration (C

Indexed as

Area Under CurveCross-Over StudiesDrug CombinationsFood-Drug InteractionsHealthy VolunteersPyrimidinesSulfonamidesTabletsTadalafilTherapeutic EquivalencyAdministration, OralAdolescentAdultFastingFemaleHumansDrug CombinationsmacitentanPyrimidinesSulfonamidesTabletsTadalafilbioequivalencefixed‐dose combinationfood effectmacitentanpulmonary arterial hypertensiontadalafil

Identifiers

PMID38764241
PMCPMC11103125

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.