Trial Profile
A Single-center, Open-label, Single-dose, Randomized, 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Bioequivalence of the Dispersible Final Market Image (FMI) Macitentan Tablet (4 x 2.5 mg) and the Opsumit Tablet (10 mg) in Fasted Conditions
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 06 Nov 2023
Price :
$35
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At a glance
- Drugs Macitentan (Primary)
- Indications Congenital heart defects; Eisenmenger complex; Heart failure; Pulmonary arterial hypertension; Pulmonary hypertension
- Focus Pharmacokinetics
- Sponsors Actelion Pharmaceuticals
Most Recent Events
- 12 Sep 2023 Primary endpoint has been met. (Area Under the Plasma Analyte Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Macitentan), as per results presented at the 2023 American College of Clinical Pharmacology Annual Meeting.
- 12 Sep 2023 Primary endpoint has been met. (Area Under the Plasma Analyte Concentration Versus Time Curve From Time Zero To Time of the Last Quantifiable (Non-below Quantification Limit [Non-BQL]) Concentration (AUC [0-last]) of Macitentan), as per results presented at the 2023 American College of Clinical Pharmacology Annual Meeting.
- 12 Sep 2023 Primary endpoint has been met. (Maximum Observed Plasma Analyte Concentration (Cmax) of Macitentan), as per results presented at the 2023 American College of Clinical Pharmacology Annual Meeting.