Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults
Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults
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.
Inclusion Criteria:

 -  Signed informed consent

 -  Healthy on the basis of the physical examination, vital signs (systolic and diastolic
 blood pressure, heart rate), 12-lead ECG, and laboratory tests performed at screening

 Exclusion Criteria:

 -  History or clinical evidence of any disease and/or condition, which might interfere
 with the absorption, distribution, metabolism or excretion of the study drug

 -  Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal
 reactions

 -  History or clinical evidence of alcoholism or drug abuse within the 3 -year period
 prior to screening

 -  Excessive caffeine consumption

 -  Smoking within 3 months prior to screening and inability to refrain from smoking
 during the course of the study

 -  Previous treatment with any prescribed medications (including vaccines) or over-the
 counter medications within 2 weeks prior to first study drug administration

 -  Loss of 250 mL or more of blood within 3 months prior to screening

 -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
 full participation in the study or compliance with the protocol