NCT06058689

A Pilot Bioequivalence Study of Pomalidomide

A Pilot, Open-label, Randomized, Two-Way Crossover, Single-Dose Bioequivalence Study of Pomalidomide Under Fasting Condition in Indian Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Megalabs · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Pilot bioequivalence trial of two pomalidomide formulations consisting in 4 mg oral capsules.

Detailed description

An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover assignment, bioequivalence study of Pomalidomide 4 mg Capsules of Mega Labs S.A and Pomalyst® (Pomalidomide) 4 mg capsules of Celgene International SARL, Boudry, Switzerland in healthy, adult, human male subjects under fasting condition.

Conditions

• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Pomalidomide 4 MG Oral Capsule	A single dose of 4 mg Pomalidomide per os, capsule, 4 mg, per period

Timeline

• Start date: 2024-09-15
• Primary completion: 2024-11-15
• Completion: 2025-03-15
• First posted: 2023-09-28
• Last updated: 2023-09-28

Locations

1 site across 1 country: India