Bioequivalence and the food effect of macitentan/tadalafil 10/20 fixed-dose combination tablets versus the use of single-component tablets in healthy subjects.
Humans
Therapeutic Equivalency
Cross-Over Studies
Male
Adult
Pyrimidines
/ pharmacokinetics
Food-Drug Interactions
Tablets
Tadalafil
/ pharmacokinetics
Young Adult
Female
Drug Combinations
Healthy Volunteers
Sulfonamides
/ pharmacokinetics
Area Under Curve
Middle Aged
Administration, Oral
Fasting
Adolescent
bioequivalence
fixed‐dose combination
food effect
macitentan
pulmonary arterial hypertension
tadalafil
Journal
Pharmacology research & perspectives
ISSN: 2052-1707
Titre abrégé: Pharmacol Res Perspect
Pays: United States
ID NLM: 101626369
Informations de publication
Date de publication:
Jun 2024
Jun 2024
Historique:
revised:
05
04
2024
received:
02
01
2024
accepted:
08
04
2024
medline:
20
5
2024
pubmed:
20
5
2024
entrez:
20
5
2024
Statut:
ppublish
Résumé
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
Substances chimiques
macitentan
0
Types de publication
Journal Article
Randomized Controlled Trial
Clinical Trial, Phase I
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1202Subventions
Organisme : Janssen Research and Development
Informations de copyright
© 2024 Actelion Pharmaceuticals Ltd. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd.
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