Trial reportClinical pharmacology in drug development2025
Pharmacokinetics and Bioequivalence of a Novel Extended-Release Formulation of Methylphenidate Hydrochloride for Attention-Deficit/Hyperactivity Disorder.
Trial report in Clinical pharmacology in drug development, 2025. 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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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
3 authors.
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Abstract
Extended-release (ER) formulations of the stimulant methylphenidate are commonly used to treat attention-deficit/hyperactivity disorder in both children and adults. Previous studies have shown that the clinical effectiveness of long-acting methylphenidate formulations is closely tied to the drug's pharmacokinetic (PK) profile, highlighting the need for consistency in drug exposure. ODX-methylphenidate ER uses an osmotic pump design to provide controlled release of drug over the course of the day. In these similarly designed 4-period replicate crossover studies, the PK profile of ODX-methylphenidate ER was compared to the reference product, osmotic release oral system (OROS)-methylphenidate ER, in healthy subjects in the fasted state. In the first trial (N = 60), a single 72-mg tablet of ODX-methylphenidate ER was compared to two 36-mg tablets of OROS-methylphenidate ER, while in the second trial (N = 36), a single 54-mg tablet of ODX-methylphenidate ER was compared to a 54-mg tablet of OROS-methylphenidate ER. The 2 studies had very comparable results, demonstrating similar PK parameters for the 2 products, including during the critical 7-12-hour postdose window. Statistical bioequivalence between the 2 formulations was confirmed for maximum drug concentration, area under the concentration-time curve from time 0 to 3 hours after dosing (AUC
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