NCT06484673

Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets

Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in Healthy Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Bosentan 32 mg Dispersible Tablets versus Tracleer® 32 mg Tablets for Oral Suspension (Tracleer® 32 mg Dispersible Tablet) (Bosentan), in healthy subjects under fasting condition.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Bosentan Dispersible Tablets	1 tablet of 32 mg Bosentan
DRUG	Tracleer Tablet for Oral Suspension	1 tablet of 32 mg Bosentan

Timeline

• Start date: 2024-04-21
• Primary completion: 2024-05-22
• Completion: 2024-05-27
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

1 site across 1 country: Jordan