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Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.

17. september 2013 opdateret af: AstraZeneca

An Open-label, Randomised, 3-period, 3-treatment, Crossover, Single-centre, Single-dose, Bioavailability Study With Alternative Methods of Administration of Crushed Ticagrelor Tablets, 90 mg, Compared to Whole Ticagrelor Tablets, 90 mg, in Healthy Volunteer

Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered orally or through nasogastric tubes compared to whole ticagrelor tablets given orally

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy male and female volunteers aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture
  • Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg (110 pounds [lbs]) and no more than 100 kg (220 lbs).
  • Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
  • History of haemophilia, von Willebrand's disease, lupus anticoagulant or other diseases/syndromes that can either alter or increase the propensity for bleeding
  • A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 3 months prior to the screeening visit; or history suggestive of peptic ulcer disease
  • History of frequent and/or significant nose bleed or clinically significant non traumatic bleed, bruise/haematoma or any other clinically significant bleeding risk, as judged by the Investigator

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A
Ticagrelor 90 mg as a whole tablet
Medicin: Ticagrelor 90 mg whole tablet
Ticagrelor 90 mg whole tablet administered as a single oral dose
Eksperimentel: B
Ticagrelor 90 mg tablet crushed and suspended in water
Medicin: Ticagrelor 90 mg tablet crushed
Ticagrelor 90 mg crushed and suspended in water
Eksperimentel: C
Dispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach
Medicin: Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube
Dispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor
Tidsramme: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor
Tidsramme: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor
Tidsramme: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor
Tidsramme: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

Sekundære resultatmål

Resultatmål
Tidsramme
Description of the safety profile in terms of adverse events (AE)
Tidsramme: From first dose through to the follow-up visit.
From first dose through to the follow-up visit.
Description of the safety profile in terms of laboratory variables
Tidsramme: Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up
Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up
Description of the safety profile in terms of vital signs
Tidsramme: Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up
Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up
Description of the safety profile in terms of physical examination findings
Tidsramme: Physical examination at screening, pre-dose, Day 3 and follow-up
Physical examination at screening, pre-dose, Day 3 and follow-up
Description of the safety profile in terms of Electrocardiogram (ECG)
Tidsramme: ECGs at screening, Day 3 and follow-up
ECGs at screening, Day 3 and follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: Judith Hsia, MD, Astrazeneca, Wilmington, US
  • Studiestol: Mirjana Kujacic, MD, AstraZeneca Mölndal, Sweden
  • Ledende efterforsker: Saeed Kahn, MBBS, Quintiles London, United Kingdom

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2013

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Faktiske)

1. september 2013

Datoer for studieregistrering

Først indsendt

25. juni 2013

Først indsendt, der opfyldte QC-kriterier

25. juni 2013

Først opslået (Skøn)

27. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D5130C00076

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Biotilgængelighed Heathy Frivillige

Kliniske forsøg med Ticagrelor 90 mg whole tablet

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