NCT04101370

Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects

Two-way Crossover, Open-label, Single-dose, Bioequivalence Study of Bosentan (LLC "GEROPHARM", Russia) 125 mg Tablets Immediate Release (IR )Versus Tracleer® (Actelion Pharmaceuticals Ltd., Switzerland) 125 mg Tablets IR in Normal Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Geropharm · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion)

Detailed description

Study to evaluate the bioequivalence of orally administered bosentan preparations, immediate release tablets, 125 mg in normal healthy subjects under fasting conditions

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Bosentan 125 mg	Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition
DRUG	Tracleer 125Mg Tablet	Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition

Timeline

• Start date: 2018-05-24
• Primary completion: 2018-06-20
• Completion: 2018-06-20
• First posted: 2019-09-24
• Last updated: 2019-09-24

Locations

1 site across 1 country: Russia