The average plasma exposure to bosentan at steady state (AUCss) in pediatric patients with PAH aged 3 to 15 years treated with 31.25, 62.5 or 125 mg (approximately 2 mg/kg) film-coated tablet twice daily is 37% lower than that observed in adult patients with PAH receiving 125 mg film-c...
The method was successfully applied to a bioequivalence study of 125mg tablet formulation (test and reference) in 12 healthy Indian male subjects under fasting condition. The ratios of mean log-transformed values of Cmax, AUC0t and AUC0–inf and their 90% CIs varied from 91.3 to 104.7%. ...