Evidence map›Paper›PMID 31724343›Full record

Trial reportClinical pharmacology in drug development2020

Bioequivalence and Food Effect Assessment of 2 Fixed-Dose Combination Formulations of Dolutegravir and Lamivudine.

Teodora Pene Dumitrescu, Kavita Peddiraju, Caifeng Fu, Kalpana Bakshi, Shui Yu, Zhiping Zhang, Allan R Tenorio, Chris Spancake, Shashidhar Joshi, Allen Wolstenholme and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2020. 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 32% 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. The Hepatoprotective Effects ofPlants (Basel, Switzerland) · 2023
    Review
  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

11 authors at 5 institutions in 4 countries.

Teodora Pene DumitrescuClinical Pharmacology Modeling and Simulation, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
Kavita PeddirajuPharma R&D, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
Caifeng FuPAREXEL International, Durham, North Carolina, USA.
Kalpana BakshiPharma R&D, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
Shui YuPAREXEL International, Durham, North Carolina, USA.
Zhiping ZhangPAREXEL International, Durham, North Carolina, USA.
Allan R TenorioClinical Development, ViiV Healthcare, Durham, North Carolina, USA.
Chris SpancakeMedicinal Science and Technology, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
Shashidhar JoshiBiostatistics, GlaxoSmithKline India, Mumbai, India.
Allen WolstenholmePharma R&D, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
Kimberly AdkisonClinical Pharmacology, ViiV Healthcare, Durham, North Carolina, USA.
GlaxoSmithKline (United States) · USPAREXEL International (United Kingdom) · GBViiV Healthcare (Spain) · ESGlaxoSmithKline (India) · INPAREXEL International (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This single-dose study evaluated the bioequivalence, food effect, and safety of 2 experimental, 2-drug, fixed-dose formulations of 50 mg dolutegravir and 300 mg lamivudine (formulation AH and formulation AK) as compared with coadministration of single-entity tablets of 50 mg dolutegravir and 300 mg lamivudine (reference). In fasted subjects, formulation AH lamivudine exposure was similar to the reference; however, dolutegravir exposure was consistently higher in formulation AH, with area under the concentration-time curve (AUC) and maximum concentration (C

Indexed as

Administration, OralAdultArea Under CurveBody Mass IndexDolutegravirDrug Therapy, CombinationFastingFemaleFoodHeterocyclic Compounds, 3-RingHIV-1HIV InfectionsHIV Integrase InhibitorsHumansLamivudineMaleDolutegravirHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsLamivudineOxazinesPiperazinesPyridonesReverse Transcriptase InhibitorsbioequivalencedolutegravirHIVlamivudine

Identifiers

PMID31724343
PMCPMC7028125
OpenAlexW2983863863

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.