NCT06932198

Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag)

Randomized, Single Oral Dose, Two-period, Two-treatment, Two-sequence Open-label, Crossover, Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag), in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Randomized, single oral dose, two-period, two-treatment, two-sequence open-label, crossover, bioequivalence study to compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag), in healthy subjects under fed conditions.

Conditions

• Pulmonary Arterial Hypertension (PAH)

Interventions

Type	Name	Description
DRUG	Selexipag Film Coated Tablets	1 tablet
DRUG	Uptravi® Film Coated Tablets	1 tablet

Timeline

• Start date: 2025-01-09
• Primary completion: 2025-03-03
• Completion: 2025-03-25
• First posted: 2025-04-17
• Last updated: 2025-04-22

Locations

1 site across 1 country: Jordan