Trial reportClinical drug investigation2014
Pharmacokinetics of lacosamide and omeprazole coadministration in healthy volunteers: results from a phase I, randomized, crossover trial.
Trial report in Clinical drug investigation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- Effects of Mexiletine and Lacosamide on Nerve Excitability in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.Clinical pharmacology and therapeutics · 2022Trial
- Elevated Serum Concentrations of Lacosamide and Perampanel in a Pediatric Patient Following Coadministration of Clarithromycin forThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Development and validation of a population pharmacokinetic model for lacosamide in adult patients with epilepsy to inform precision dosing.BMC pharmacology & toxicology · 2026Article
- Pharmacokinetics of CYP2C19- and CYP3A4-Metabolized Drugs in Cirrhosis Using a Whole-Body PBPK Approach.Pharmaceutics · 2025Article
- Impact of Age and Concurrent Antiseizure Medication Use on Lacosamide Dose to Concentration Ratio and Dosing in Pediatric Patients.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Development of a UPLC-MS/MS method for the determination of lacosamide and its metabolite and its application to drug-drug interaction.Frontiers in pharmacology · 2023Article
- Is Therapeutic Drug Monitoring of Lacosamide Needed in Patients with Seizures and Epilepsy?European journal of drug metabolism and pharmacokinetics · 2020Review
- Pharmacokinetic Considerations with the Use of Antiepileptic Drugs in Patients with HIV and Organ Transplants.Current neurology and neuroscience reports · 2018Review
- Pharmacokinetics and Drug Interaction of Antiepileptic Drugs in Children and Adolescents.Paediatric drugs · 2018Review
- The Pharmacology and Toxicology of Third-Generation Anticonvulsant Drugs.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2017Review
- The efficacy of lacosamide as monotherapy and adjunctive therapy in focal epilepsy and its use in status epilepticus: clinical trial evidence and experience.Therapeutic advances in neurological disorders · 2017Review
- Clinical pharmacokinetic and pharmacodynamic profile of lacosamide.Clinical pharmacokinetics · 2015Review
- Effect of age and sex on lacosamide pharmacokinetics in healthy adult subjects and adults with focal epilepsy.Clinical drug investigation · 2015Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe antiepileptic drug lacosamide has a low potential for drug-drug interactions, but is a substrate and moderate inhibitor of the cytochrome P450 (CYP) enzyme CYP2C19.
objectiveThis phase I, randomized, open-label, two-way crossover trial evaluated the pharmacokinetic effects of lacosamide and omeprazole coadministration.
methodsHealthy, White, male volunteers (n = 36) who were not poor metabolizers of CYP2C19 were randomized to treatment A (single-dose 40 mg omeprazole on days 1 and 8 together with 6 days of multiple-dose lacosamide [200-600 mg/day] on days 3-8) and treatment B (single doses of 300 mg lacosamide on days 1 and 8 with 7 days of 40 mg/day omeprazole on days 3-9) in pseudorandom order, separated by a ≥ 7-day washout period. Area under the concentration-time curve (AUC) and peak concentration (C(max)) were the primary pharmacokinetic parameters measured for lacosamide or omeprazole administered alone (reference) or in combination (test). Bioequivalence was determined if the 90 % confidence interval (CI) of the ratio (test/reference) fell within the acceptance range of 0.8-1.25.
resultsThe point estimates (90 % CI) of the ratio of omeprazole + lacosamide coadministered versus omeprazole alone for AUC (1.098 [0.996-1.209]) and C(max) (1.105 [0.979-1.247]) fell within the acceptance range for bioequivalence. The point estimates (90 % CI) of the ratio of lacosamide + omeprazole coadministration versus lacosamide alone also fell within the acceptance range for bioequivalence (AUC 1.133 [1.102-1.165]); C(max) 0.996 (0.947-1.047).
conclusionSteady-state lacosamide did not influence omeprazole single-dose pharmacokinetics, and multiple-dose omeprazole did not influence lacosamide single-dose pharmacokinetics.
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Registered trials
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