Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg

Exclusion Criteria

• •Known allergic reactions or hypersensitivity to selexipag or any excipient of the drug formulation used in this study.
• •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of selexipag.
• •Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
• •Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
• •Treatment with selexipag or another investigational drug within 1 month prior to Screening or 5 half-lives, whichever is longer.
• •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
• •Excessive caffeine consumption at Screening.
• •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 500 mL or more of blood within 3 months prior to Screening.
• •Positive results from the hepatitis serology (hepatitis B antigen and hepatitis C antibodies), except for vaccinated subjects or subjects with past but resolved hepatitis, at Screening.
• •Positive results from the human immunodeficiency virus serology at Screening.
• •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
• •Legal incapacity or limited legal capacity at Screening.