Healthy Subjects Clinical Trial
Official title:
Single-center, Open-label, Randomized, Two-treatment, Single-dose, Crossover Study in Healthy Subjects to Investigate the Biocomparison of the Adult and Pediatric Formulation of Macitentan
A study conducted in healthy adults to investigate if a new macitentan tablet leads to the same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as the marketed macitentan tablet.
The purpose of this study is to establish biocomparison of 2 types of tablets containing
macitentan: a pediatric dispersible tablet and the adult film-coated tablet. A single oral
dose of each tablet will be given to healthy subjects on 2 different periods separated by a
washout phase of 10 to 14 days.
Biocomparison will be based on the comparison of the pharmacokinetic parameters of
macitentan with the two types of tablets using specific statistical methods. The
pharmacokinetic parameters will be considered equivalent if specific criteria defined in the
study protocol are met.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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