Why the study?
What are the multiple-dose pharmacokinetics, safety, and tolerability of bosentan in healthy male volunteers?
Population
Healthy male volunteers
Comparison
Oral bosentan 100, 200, 500, and 1000 mg once… vs Placebo
Design
RCT, double-blind
Follow-up
8 days
Authors
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Bosentan auto-induction may require dosing adjustments after initiation; extends time-dependent PK data for endothelin receptor antagonists.
What are the multiple-dose pharmacokinetics, safety, and tolerability of bosentan in healthy male volunteers?
Bosentan is well tolerated in healthy males and induces its own metabolism, leading to increased clearance and decreased plasma concentrations over an 8-day period.
Weber et al. (1999) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: