Evidence map›Paper›PMID 31140114›Full record

Trial reportClinical drug investigation2019

Development Strategy and Relative Bioavailability of a Pediatric Tablet Formulation of Ticagrelor.

Mohammad Niazi, Jenny Wissmar, Anders R Berggren, Christer Karlsson, Per Johanson

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03126695 (An Open-label, Randomized, 4-period, 4-treatment, Cross-over, Single-center, Single-dose Study to Assess the Relative Bioavailability of Ticagrelor in Different Formulations in Healthy Adult Subjects), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.1field-weighted citation impact, top 19% 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.

NCT03126695 phase1completednot on this map

An Open-label, Randomized, 4-period, 4-treatment, Cross-over, Single-center, Single-dose Study to Assess the Relative Bioavailability of Ticagrelor in Different Formulations in Healthy Adult Subjects

TypeinterventionalSponsorAstraZenecaRan2017 to 2017Enrolled44ConditionsSickle Cell DiseaseArmsTicagrelor granule, Ticagrelor pediatric tablets, Ticagrelor pediatric tablets suspended in water, Ticagrelor immediate release (IR) tablets (Commercial tablet)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. 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

5 authors at 2 institutions in 2 countries.

Mohammad NiaziQuantitative Clinical Pharmacology, Early Clinical Development, AstraZeneca Gothenburg, Mölndal, Sweden. mohammad.niazi@astrazeneca.com.ORCID http://orcid.org/0000-0002-5468-5469
Jenny WissmarGlobal Medicines Development, AstraZeneca Gothenburg, Mölndal, Sweden.
Anders R BerggrenGlobal Medicines Development, AstraZeneca Gothenburg, Mölndal, Sweden.
Christer KarlssonPharmaceutical Technology and Development, AstraZeneca Gothenburg, Mölndal, Sweden.
Per JohansonGlobal Medicines Development, AstraZeneca Gothenburg, Mölndal, Sweden.
AstraZeneca (Sweden) · SEAstraZeneca (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveTicagrelor is a P2Y

methodsWe conducted a randomized, four-period, cross-over, single-dose study. Pharmacokinetic parameters were assessed for ticagrelor and its active metabolite AR-C124910XX. Bioequivalence was concluded if the 90% confidence intervals of the maximum plasma concentration and area under the plasma concentration-time curve ratios were contained completely within the 80.00-125.00% limits for ticagrelor/AR-C124910XX.

resultsForty-four healthy adults (95% white; 57% male) were included. Similar bioavailability of ticagrelor (and AR-C124910XX) was demonstrated for all comparisons tested. Ticagrelor pediatric tablets taken whole were bioequivalent to pediatric tablets suspended in water. The plasma concentration-time profiles for ticagrelor and AR-C124910XX were similar, showing rapid ticagrelor absorption and AR-C124910XX formation. All formulations were well tolerated.

conclusionSimilar bioavailability of a new pediatric dispersible tablet formulation of ticagrelor for use across a wide age range of pediatric patients was demonstrated compared with other oral ticagrelor formulations. CLINICALTRIALS. GOV IDENTIFIER: NCT03126695. EUDRACT: 2017-000371-93.

Indexed as

TabletsAdenosineAdolescentBiological AvailabilityChildCross-Over StudiesFemaleHumansMalePlatelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsTherapeutic EquivalencyTicagrelorAdenosineAR C124910XXPlatelet Aggregation InhibitorsPurinergic P2Y Receptor AntagonistsTabletsTicagrelor

Identifiers

PMID31140114
OpenAlexW2946838061

What OpenQuestion holds

Textmetadata
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.