NCT06834451

Bioequivalence Study of Revolade® Eltrombopag 50 mg

Bioequivalence Study of Revolade® Eltrombopag 50 mg Tablets - Novartis Vs Myelone ® Eltrombopag 50 mg Tablets - Colompack / Immediate Release Tablets in Healthy Subjects Under Fasting Condition

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centro de Atencion e Investigacion Medica · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence Study

Detailed description

A bioequivalence study of Eltrombopag will be developed in 30 healthy subjects, under fasting condition, following the design: Open-label, crossover, randomized, single-dose design of 50 mg Eltrombopag tablets/immediate release tablets, with two treatments, two periods, two sequences in healthy volunteers in fasting condition, with a washout time of 15 days between each dose

Conditions

• Healthy
• Healthy Donors

Interventions

Type	Name	Description
DRUG	Revolade®	Tableta 50 mg Reference
DRUG	Eltrombopag (EPAG)	Tableta 50 mg

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2025-02-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: Colombia