Evidence map›Paper›PMID 29150845›Full record

Trial reportClinical pharmacology and therapeutics2018

Effect of Sorbitol on the Pharmacokinetic Profile of Lamivudine Oral Solution in Adults: An Open-Label, Randomized Study.

Kimberly Adkison, Allen Wolstenholme, Yu Lou, Zhiping Zhang, Amy Eld, Teodora Perger, Harald Vangerow, Katy Hayward, Mark Shaefer, Cynthia McCoig

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02634073 (An Open-label Single-Center, 4-Period William's Cross-Over Design Drug Interaction Trial to Determine the Effects of Sorbitol-Containing Solutions on Lamivudine Exposure Following Administration of Lamivudine Oral Solution in Healthy Adult Subjects), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 13% of its field
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.

NCT02634073 phase4completednot on this map

An Open-label Single-Center, 4-Period William's Cross-Over Design Drug Interaction Trial to Determine the Effects of Sorbitol-Containing Solutions on Lamivudine Exposure Following Administration of Lamivudine Oral Solution in Healthy Adult Subjects

TypeinterventionalSponsorViiV HealthcareRan2016 to 2016Enrolled16ConditionsInfection, Human Immunodeficiency VirusArmsLamivudine, Sorbitol
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
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  8. Review
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  14. Twenty-Five Years of Lamivudine: Current and Future Use for the Treatment of HIV-1 Infection.Journal of acquired immune deficiency syndromes (1999) · 2018
    Review
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

10 authors at 5 institutions in 3 countries.

Kimberly AdkisonViiV Healthcare, Research Triangle Park, North Carolina, USA.
Allen WolstenholmeGlaxoSmithKline, Collegeville, Pennsylvania, USA.
Yu LouPAREXEL International, Durham, North Carolina, USA.
Zhiping ZhangPAREXEL International, Durham, North Carolina, USA.
Amy EldGlaxoSmithKline, Collegeville, Pennsylvania, USA.
Teodora PergerViiV Healthcare, Brentford, Middlesex, UK.
Harald VangerowGlaxoSmithKline, Uxbridge, Middlesex, UK.
Katy HaywardViiV Healthcare, Brentford, Middlesex, UK.
Mark ShaeferViiV Healthcare, Research Triangle Park, North Carolina, USA.
Cynthia McCoigViiV Healthcare, Tres Cantos, Spain.
GlaxoSmithKline (United States) · USPAREXEL International (United States) · USViiV Healthcare (United Kingdom) · GBGlaxoSmithKline (United Kingdom) · GBViiV Healthcare (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In children aged ≤4 years, the relative bioavailability of lamivudine oral solution was 37% lower than that of a tablet formulation. An open-label, four-way crossover study was conducted in healthy adults to evaluate the effect of sorbitol, a common liquid excipient, on the pharmacokinetics of lamivudine oral solution (ClinicalTrials.gov identifier, NCT02634073). Sixteen subjects were randomized to one of four sequences consisting of four doses of lamivudine 300 mg (10 mg/mL) alone or with sorbitol 3.2, 10.2, or 13.4 g. Sorbitol 3.2, 10.2, and 13.4 g decreased lamivudine maximum concentration (C

Indexed as

Administration, OralAdultAnti-HIV AgentsArea Under CurveBiological AvailabilityCross-Over StudiesDiureticsDose-Response Relationship, DrugDrug InteractionsFemaleHumansIntestinal AbsorptionLamivudineMaleMiddle AgedPharmaceutical SolutionsAnti-HIV AgentsDiureticsLamivudinePharmaceutical SolutionsSorbitol

Identifiers

PMID29150845
PMCPMC5836851
OpenAlexW2768099625

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.