Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects

This study evaluated the bioequivalence and tolerability of a test pomalidomide formulation (Xetrane® 4 mg hard capsule) compared with the reference formulation (Imnovid® 4 mg hard capsule) in healthy male subjects under fasting conditions. The study used an open-label, randomized, single-dose, two-treatment, two-sequence, two-period crossover design. Pharmacokinetic parameters including Cmax and AUC0-t were compared between formulations. Bioequivalence was concluded if the 90% confidence intervals for the geometric mean ratios of the log-transformed pharmacokinetic parameters were within the predefined acceptance range of 80.00% to 125.00%. Safety and tolerability were also assessed.

NCT Number	NCT07694011
Lead Sponsor	Knight Therapeutics (USA) Inc Collaborators: Laboratorio LKM Chile SpA (Knight Therapeutics Company)
Conditions	Pomalidomide Bioequivalence Study in Healthy Volunteers
Enrollment	34 participants
Start Date	2025-01-25
Primary Completion	2025-02-05 (estimated)
Study Completion	2025-02-07 (estimated)
Updated on ClinicalTrials.gov	2026-07-10