Evidence map›Paper›PMID 25903807›Full record

Trial reportJournal of clinical pharmacology2015

Steady-state pharmacokinetics and bioavailability of immediate-release and extended-release formulations of lamotrigine in elderly epilepsy patients: Use of stable isotope methodology.

Akshanth R Polepally, Rory P Remmel, Richard C Brundage, Ilo E Leppik, John O Rarick, R Eugene Ramsay, Angela K Birnbaum

Abstract readClinical Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Development of in vitro-in vivo correlation for establishing patient-centric quality standards of dissolution for lamotrigine extended-release tablets.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2025
    Article
  2. Late-Stage Isotopic Exchange of Primary Amines.Journal of the American Chemical Society · 2023
    Article
  3. Article
  4. Review
  5. Effect of Spray Drying Conditions on Physical Properties ofDrug design, development and therapy · 2021
    Article
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Akshanth R PolepallyExperimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
Rory P RemmelMedicinal Chemistry, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
Richard C BrundageExperimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
Ilo E LeppikExperimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
John O RarickExperimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
R Eugene RamsayDepartment of Neurology, Ochsner Baptist Medical Center, New Orleans, LA, USA.
Angela K BirnbaumExperimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.

Funding

TREATMENT OF PATIENTS WITH PSEUDO-SEIZURESP50NS016308 · NINDS · UNIVERSITY OF MINNESOTA TWIN CITIES · PI BIRNBAUM, ANGELA K · 1985 to 2006
$8.5M
Clinical Impact of Unstable AED Levels in Elderly Nursing Home Epilepsy PatientsR01AG026390 · NIA · UNIVERSITY OF MINNESOTA · PI BIRNBAUM, ANGELA K · 2007 to 2011
$1.9M
NIA NIH HHS R01 AG026390NIA NIH HHS R01AG026390NINDS NIH HHS P50 NS016308NINDS NIH HHS P50NS16308
6 · The paper itself

Abstract

A classic 2-period crossover bioavailability study was conducted to evaluate the relative and absolute bioavailability of immediate-release (IR) and extended-release (XR) lamotrigine formulations under steady-state conditions in elderly patients with epilepsy. On treatment days, each subject's morning dose (IR or XR lamotrigine) was replaced with an intravenous 50-mg dose of stable-labeled lamotrigine. Lamotrigine concentrations were measured at 13 points between 0 and 96 hours. XR and IR lamotrigine formulations were similar with respect to steady-state area under the concentration-time curve from 0 to 24 hours (AUC0-24 h ss), average concentration (Cavg, ss), and trough concentration (Cτ, ss). A 33% lower fluctuation in concentrations with XR was observed relative to IR lamotrigine. The time to peak concentration (Tmax, ss) was delayed for XR lamotrigine (3.0 vs 1.3 hours) with lower peak concentration (15% lower). The absolute bioavailability for IR and XR formulations was 73% and 92%, respectively. The formulations were bioequivalent with respect to AUC0-24 h ss, Cτ, ss, and Cavg, ss indicating that it may be possible to switch directly from IR to XR lamotrigine without changes in the total daily dose.

Indexed as

Administration, IntravenousAdministration, OralAgedAged, 80 and overAnticonvulsantsBiological AvailabilityCarbon IsotopesCross-Over StudiesDelayed-Action PreparationsEpilepsyFemaleHumansLamotrigineMaleMiddle AgedNitrogen IsotopesAnticonvulsantsCarbon IsotopesDelayed-Action PreparationsLamotrigineNitrogen IsotopesTriazineselderlyextended-releaseimmediate-releaselamotriginestable isotope

Identifiers

PMID25903807
PMCPMC4558201

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Registered trials

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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.