Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion)
Study to evaluate the bioequivalence of orally administered bosentan preparations, immediate release tablets, 125 mg in normal healthy subjects under fasting conditions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
64
Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition
Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition
Clinical Hospital № 3
Yaroslavl, Russia
Cmax
Pharmacokinetics of bosentan by Assessment of Observed Maximum Plasma Concentration (Cmax)
Time frame: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
AUC(0-t)
Pharmacokinetics of bosentan by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Time frame: 0 hours (pre-dose), as well as at 0.5, 1, 1.5, 2, 2.5, 3, 3,5, 3,75, 4, 4.25, 4.5, 4.75, 5, 6, 8, 10, 12, 14 and 24 hour post-dose.
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