Trial reportClinical neuropharmacology
Clinical Pharmacokinetics of IPX066: Evaluation of Dose Proportionality and Effect of Food in Healthy Volunteers.
Trial report in Clinical neuropharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- How to Optimize the Effectiveness and Safety of Parkinson's Disease Therapy? - A Systematic Review of Drugs Interactions with Food and Dietary Supplements.Current neuropharmacology · 2022Pooled it
- Effect of Concomitant Medications on the Safety and Efficacy of Extended-Release Carbidopa-Levodopa (IPX066) in Patients With Advanced Parkinson Disease: A Post Hoc Analysis.Clinical neuropharmacologyTrial
- Development of an in-situ forming implant system for levodopa and carbidopa for the treatment of parkinson's disease.Drug delivery and translational research · 2025Article
- Medical Management and Prevention of Motor Complications in Parkinson's Disease.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020Review
- Therapeutic Strategies to Treat or Prevent Off Episodes in Adults with Parkinson's Disease.Drugs · 2020Review
- Review
- From medications to surgery: advances in the treatment of motor complications in Parkinson's disease.Drugs in context · 2019Review
- Extended-release oral capsule of carbidopa-levodopa in Parkinson disease.Therapeutic advances in neurological disorders · 2018Review
- Biopharmaceutical Evaluation and CMC Aspects of Oral Modified Release Formulations.The AAPS journal · 2017Article
- Pharmacokinetics of RytaryClinical pharmacokinetics · 2017Review
- Application of Pharmacokinetics and Pharmacodynamics in Product Life Cycle Management. A Case Study with a Carbidopa-Levodopa Extended-Release Formulation.The AAPS journal · 2017Review
- Recent advances in treating Parkinson's disease.F1000Research · 2017Review
- Novel Levodopa Formulations for Parkinson's Disease.CNS drugs · 2016Review
- Carbidopa/Levodopa ER Capsules (Rytary(®), Numient™): A Review in Parkinson's Disease.CNS drugs · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesIPX066 is an oral, extended-release capsule formulation of carbidopa-levodopa (CD-LD) available in 4 strengths. The goals of this investigation were to assess the dose proportionality of IPX066 and to study the effects of a high-fat, high-calorie meal and of sprinkling the capsule contents on applesauce on the pharmacokinetics of IPX066 in healthy volunteers.
methodsThree open-label studies were conducted. In the first study, subjects received 1 capsule of each IPX066 strength (23.75-95, 36.25-145, 48.75-195, and 61.25-245 mg of CD-LD). In the second study, subjects received 1 and 2 capsules of IPX066 245-mg LD under fasting conditions. In the third study, subjects received 2 capsules of IPX066 245-mg LD under 3 conditions: fasting; following a high-fat, high-calorie breakfast; and with the capsule contents sprinkled on applesauce under fasting conditions.
resultsPeak plasma concentrations (Cmax) and systemic exposure (AUCt, AUCinf) for LD and CD increased dose-proportionally over the range of the IPX066 capsule strengths. Comparison of 1 and 2 IPX066 245-mg LD capsules showed dose-proportional pharmacokinetics for Cmax and AUCt. Sprinkling the capsule contents on applesauce did not affect the pharmacokinetics. A high-fat, high-calorie meal delayed the initial increase in LD concentration by approximately 1 to 2 hours, reduced Cmax by 21%, and increased AUCinf by 13% compared with the fasted state.
conclusionsIPX066 shows dose-proportional pharmacokinetics. Sprinkling the capsule contents on applesauce does not affect the pharmacokinetics; a high-fat, high-calorie meal delayed absorption by 1 to 2 hours, slightly reduced Cmax, and slightly increased extent of absorption.
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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.