Evidence map›Paper›PMID 28168828›Full record

Trial reportClinical pharmacology in drug development2017

Relative Bioavailability of a Dolutegravir Dispersible Tablet and the Effects of Low- and High-Mineral-Content Water on the Tablet in Healthy Adults.

Ann M Buchanan, Michael Holton, Ian Conn, Mark Davies, Mike Choukour, Brian R Wynne

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 34% 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.

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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. 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

6 authors at 4 institutions in 3 countries.

Ann M BuchananViiV Healthcare, Research Triangle Park, NC, USA.
Michael HoltonGlaxoSmithKline, Harlow, Essex, UK.
Ian ConnGlaxoSmithKline, Harlow, Essex, UK.
Mark DaviesGlaxoSmithKline, Ware, Hertfordshire, UK.
Mike ChoukourPAREXEL, Waltham, MA, USA.
Brian R WynneViiV Healthcare, Collegeville, PA, USA.
GlaxoSmithKline (United Kingdom) · GBPAREXEL International (United States) · USTriangle · USViiV Healthcare (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dolutegravir (DTG) is approved in the United States to treat HIV-1-infected patients weighing ≥30 kg. A dispersible DTG tablet formulation was recently developed for pediatric patients. This study compares the pharmacokinetics (PK) of the dispersible tablet with that of a previously evaluated granule formulation. In this randomized, open-label, crossover study, 15 healthy adults received single oral doses of DTG 20 mg every 7 days across 5 treatment arms: granules consumed immediately after mixture with purified water, dispersible DTG consumed immediately after reconstitution in low-mineral-content (LMC) or high-mineral-content (HMC) water, and dispersible DTG consumed 30 minutes after dispersal in LMC or HMC water. Primary endpoints were bioavailability of immediately consumed dispersible tablet in LMC water relative to granule formulation reconstituted in purified water and PK of the dispersible tablet. Secondary endpoints included tolerability and palatability. The DTG dispersible tablet showed equivalent exposures to the granule formulation with geometric least-squares mean treatment ratios of 1.06 and 1.12 for AUC

Indexed as

AdultArea Under CurveBiological AvailabilityCross-Over StudiesDolutegravirFemaleHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsHumansLeast-Squares AnalysisMaleMiddle AgedMineralsOxazinesPiperazinesPyridonesDolutegravirHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsMineralsOxazinesPiperazinesPyridonesTabletsWaterbioavailabilitydispersible tabletdolutegravirgranulepediatric

Identifiers

PMID28168828
PMCPMC5697680
OpenAlexW2586233814

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.