{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T09:03:13Z","timestamp":1784624593067,"version":"3.55.0"},"reference-count":29,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T00:00:00Z","timestamp":1784073600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Laboratorio LKM Chile SpA","award":["PRO-BEQ-PMD-002"],"award-info":[{"award-number":["PRO-BEQ-PMD-002"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>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\u2013refractory 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\u00ae 4 mg hard capsule (Laborat\u00f3rio LKM S.A., Argentina), and the reference product, Imnovid\u00ae 4 mg hard capsule (Celgene International S\u00e0rl), 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\u2013t were 106.24% (100.77\u2013112.00) and 94.67% (91.61\u201397.82), respectively. Both formulations were well tolerated. Bioequivalence between Xetrane\u00ae and Imnovid\u00ae was demonstrated in accordance with regulatory criteria. NCT07694011.<\/jats:p>","DOI":"10.3390\/ph19071089","type":"journal-article","created":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T01:05:07Z","timestamp":1784163907000},"page":"1089","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Bioequivalence Study Comparing Two Pomalidomide Hard Capsule Formulations in Healthy Chilean Subjects"],"prefix":"10.3390","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1684-6591","authenticated-orcid":false,"given":"Marcelo Gomes","family":"Davan\u00e7o","sequence":"first","affiliation":[{"name":"Medical & Clinical Affairs Department, United Medical Ltd. (A Knight Therapeutics Company), Sao Paulo 04085-001, SP, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tha\u00eds Pereira","family":"Vespasiano","sequence":"additional","affiliation":[{"name":"Medical & Clinical Affairs Department, United Medical Ltd. (A Knight Therapeutics Company), Sao Paulo 04085-001, SP, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2695-094X","authenticated-orcid":false,"given":"Jess\u00e9","family":"Moisan","sequence":"additional","affiliation":[{"name":"Medical & Clinical Affairs Department, Knight Therapeutics Inc., Montreal, QC H4M 2P2, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oscar","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"R&D Department, Laboratorio LKM S.A. (A Knight Therapeutics Company), Buenos Aires C1179, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milesa","family":"Sarmiento","sequence":"additional","affiliation":[{"name":"R&D Department, Laboratorio LKM S.A. (A Knight Therapeutics Company), Buenos Aires C1179, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M\u00e9lanie","family":"Groleau","sequence":"additional","affiliation":[{"name":"Medical & Clinical Affairs Department, Knight Therapeutics Inc., Montreal, QC H4M 2P2, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,15]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"907","DOI":"10.1093\/jnci\/djae321","article-title":"The global multiple myeloma incidence and mortality burden in 2022 and predictions for 2045","volume":"117","author":"Mafra","year":"2025","journal-title":"JNCI J. Natl. 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