Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2026
Bioequivalence of netupitant and palonosetron (NEPA) oral suspension and hard capsules in healthy individuals: results from an open-label, randomized, two-treatment, four-period, two-sequence replicative design trial.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeNEPA, a fixed-antiemetic combination of netupitant and palonosetron, is available via two administration routes (oral and intravenous). A new oral suspension was developed to offer a more convenient option for patients. This study evaluated the bioequivalence between the oral capsule and the oral suspension.
methodsOpen-label, randomized, single-center phase I trial conducted according to a two-treatment, four-period, two-sequence replicative design. Two treatments were investigated for bioequivalence: a 10-mL oral suspension (Test [T]) and the hard capsule (Reference [R]), both containing 300 mg netupitant/0.5 mg palonosetron. Healthy individuals were randomized (1:1) to receive two doses of both Test and Reference formulations, in either T-R-T-R or R-T-R-T sequence. The primary objective was to demonstrate AUC
resultsIn total, 72 participants were included. The geometric mean plasma concentration-time profiles of netupitant and palonosetron were similar for the Test and Reference formulations. The AUC
conclusionThe NEPA oral suspension is pharmacokinetically bioequivalent to the capsule formulation in healthy individuals, with no new safety concerns. These findings support NEPA oral suspension as a potentially beneficial option for patients who prefer an oral suspension over a hard capsule and for those with swallowing difficulties. EUCT Number: 2023-504355-28-00 (25/08/2023).
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