12
Participants
Start Date
August 31, 2015
Primary Completion Date
December 31, 2015
Study Completion Date
December 31, 2015
Treatment A (adult formulation)
Single oral administration of one film-coated tablet containing 10 mg of macitentan as active substance and lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate type A, polysorbate as inactive ingredients.The film coat contains titanium dioxide, talc, xanthan gum, polyvinyl alcohol, and soy lecithin.
Treatment B (pediatric formulation)
Single oral administration of two dispersible tablets, each containing 5 mg of macitentan as active ingredient and Mannitol delta polymorphic crystals, mannitol, isomalt, isomalt agglomerated, croscarmellose sodium, and magnesium stearate as inactive ingredients.
Lead Sponsor
Actelion
INDUSTRY