Evidence map›Paper›PMID 28856602›Full record

Trial reportClinical drug investigation2017

Pharmacokinetic Profiles of Ticagrelor Orodispersible Tablets in Healthy Western and Japanese Subjects.

Renli Teng, Maria Hammarberg, Glenn F Carlson, Sara Bokelund-Singh, Terese Ruderfelt, Eva Blychert

2 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02400333 phase1completednot on this map

An Open-label, Randomised, Four-period, Four-treatment, Crossover, Single-centre, Single-dose Study to Assess the Bioavailability of Ticagrelor Orodispersible Tablets, Compared to Ticagrelor Immediate-release Tablets in Healthy Subjects

TypeinterventionalSponsorAstraZenecaRan2015 to 2015Enrolled100ConditionsBioavailability, Healthy SubjectsArmsTicagrelor OD tablet (90 mg single dose) administered with 200 ml of water, Ticagrelor OD tablet (90 mg single dose) administered without water, Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube, Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
NCT02436577 phase1completednot on this map

An Open-label, Randomized, Three-period, Three-treatment, Crossover, Single-centre, Single-dose Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Healthy Japanese Subjects.

TypeinterventionalSponsorAstraZenecaRan2015 to 2015Enrolled51ConditionsBioequivalence, Healthy Japanese Subjects, PharmacokineticsArmsTicagrelor OD tablet (90 mg single dose) administered with 150 mL of water, Ticagrelor OD tablet (90 mg single dose) administered without water, Ticagrelor IR tablet (90 mg) administered with 150 mL of water
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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.

Renli TengAstraZeneca LP, One MedImmune Way, Gaithersburg, MD, USA. renli.teng@astrazeneca.com.
Maria HammarbergAstraZeneca Pharmaceutical Technology and Development, Gothenburg, Sweden.
Glenn F CarlsonAstraZeneca LP, One MedImmune Way, Gaithersburg, MD, USA.
Sara Bokelund-SinghAstraZeneca Global Medicines Development, Gothenburg, Sweden.
Terese RuderfeltAstraZeneca Global Medicines Development, Gothenburg, Sweden.
Eva BlychertAstraZeneca Pharmaceutical Technology and Development, Gothenburg, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesTicagrelor is an antiplatelet agent for patients with acute coronary syndrome or a history of myocardial infarction. Two studies compared pharmacokinetic profiles of orodispersible (OD) ticagrelor tablets versus immediate-release (IR) tablets in Western and Japanese subjects.

methodsBoth studies were open-label, randomized, crossover, single-center trials. Thirty-six healthy subjects (94% white, 6% other race; Western study NCT02400333) and 42 Japanese healthy subjects (Japanese study NCT02436577) received a single 90-mg ticagrelor dose as an OD tablet [with/without water, and via a nasogastric tube (Western study only)], and an IR tablet; washout between treatments was ≥7 days. Assessments included ticagrelor and AR-C124910XX (active metabolite) plasma concentrations for pharmacokinetic analyses, and safety evaluations.

resultsIn the Western study, the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) for ticagrelor and AR-C124910XX maximum plasma concentration (C

conclusionsTicagrelor administered as an OD tablet to Western (without water, and via a nasogastric tube) and Japanese (with/without water) subjects was bioequivalent to the IR tablet.

Indexed as

AdenosineAdolescentAdultArea Under CurveCross-Over StudiesFemaleHumansMaleMiddle AgedPlatelet Aggregation InhibitorsTabletsTherapeutic EquivalencyTicagrelorYoung AdultAdenosineAR C124910XXPlatelet Aggregation InhibitorsTabletsTicagrelor

Identifiers

PMID28856602
PMCPMC5643369

What OpenQuestion holds

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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.