A Bioequivalence Study Comparing Two Pomalidomide Hard Capsule Formulations in Healthy Chilean Subjects.

Background

Multiple myeloma (MM) is a mature B-cell disorder characterized by the excessive production of monoclonal immunoglobulins. It is the second most common hematological cancer and predominantly affects older adults. In 2022, there were approximately 188,000 MM new cases worldwide. The disease is associated with a relapsing-refractory course. First-line therapies are often insufficient, making additional treatment options necessary. For patients refractory to lenalidomide and proteasome inhibitors (bortezomib and/or carfilzomib), pomalidomide combined with dexamethasone and an additional active agent can be used as a therapeutic strategy.

Objective

This study was conducted to evaluate the bioequivalence and tolerability of two pomalidomide hard capsule formulations to support regulatory approval of a branded generic product in Latin American countries.

Methods

An open-label, randomized, single-dose, two-treatment, two-sequence, two-period crossover study was conducted in healthy male subjects. Participants received a single oral dose of the test product, Xetrane® 4 mg hard capsule (Laboratório LKM S.A., Argentina), and the reference product, Imnovid® 4 mg hard capsule (Celgene International Sàrl), with a 7-day washout period. Blood samples were collected over 48 h post-dose. Plasma pomalidomide concentrations were determined using a validated LC-MS/MS method, and pharmacokinetic parameters were estimated using non-compartmental analysis. Findings: Thirty-four subjects were enrolled, and 29 completed the study. Geometric mean ratios (90% confidence intervals) for Cmax and AUC0-t were 106.24% (100.77-112.00) and 94.67% (91.61-97.82), respectively. Both formulations were well tolerated. Bioequivalence between Xetrane® and Imnovid® was demonstrated in accordance with regulatory criteria. NCT07694011.