Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Healthy Subjects
Interventions
DRUG

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.

DRUG

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY