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

U.S., July 10 -- ClinicalTrials.gov registry received information related to the study (NCT07694011) titled 'Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects' on July 03.

Brief Summary: This study evaluated the bioequivalence and tolerability of a test pomalidomide formulation (Xetrane(R) 4 mg hard capsule) compared with the reference formulation (Imnovid(R) 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 t...