Trial reportPharmaceutical research2014
Impact of release mechanism on the pharmacokinetic performance of PAUC metrics for three methylphenidate products with complex absorption.
Trial report in Pharmaceutical research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Ethanol Interactions With Dexmethylphenidate and dl-Methylphenidate Spheroidal Oral Drug Absorption Systems in Healthy Volunteers.Journal of clinical psychopharmacology · 2017Trial
- Absorption Differences between Immediate-Release Dexmethylphenidate and dl-Methylphenidate.Drug metabolism and disposition: the biological fate of chemicals · 2016Trial
- The Role of Early Exposure Metrics (pAUCThe AAPS journal · 2025Article
- Methylphenidate Multiphasic Release Tablet: Bioequivalence Assessment between Two Formulations Administered under Fasting and Fed Conditions.Pharmaceutics · 2023Article
- Article
- Potential for Underestimation of d-Methylphenidate Bioavailability Using Chiral Derivatization/Gas Chromatography.Drug metabolism and disposition: the biological fate of chemicals · 2019Article
- Investigation of the Discriminatory Ability of Pharmacokinetic Metrics for the Bioequivalence Assessment of PEGylated Liposomal Doxorubicin.Pharmaceutical research · 2018Article
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeInvestigate the performance of partial area under the drug concentration-time curve (PAUC) metrics (0-3 h) and (3-24 h), for Concerta, Ritalin LA and Focalin XR (different Methylphenidate modified-release formulations). The metrics have been chosen as additional BE metrics for Ritalin LA by the FDA to establish BE for these products due to the early and late peak concentrations critical for treatment of morning and afternoon symptoms of attention deficit hyperactivity disorder (ADHD).
methodsTwo-stage analysis was performed on plasma data for the methylphenidate modified-release products. Simulations using the fitted parameters determined how changes in fast absorption rate constant k0fast, and slow absorption rate constant KAslow affected curve shape and BE determination using Cmax, AUCINF and PAUC.
resultsSensitivity of the mean PAUC(test)/PAUC(reference) ratios to changes in k0fast and Kaslow were product dependent. Focalin XR mean PAUC(test)/PAUC(reference) ratios for PAUC0-3 h and PAUC3-24 h were most responsive to changes in k0Fast and Kaslow than Concerta and Ritalin LA. The PAUC(test)/PAUC(reference) ratios for (0-3 h) were not responsive to changes to Kaslow. Concerta PAUC (3-24 h) ratios were responsive to changes in Kaslow at ratios less than 1.
conclusionsResponse to PAUC(0-3 h) in the formulations was greater for k0fast than was PAUC(3-24) to changes in KAslow.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.