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Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects

29. maj 2012 opdateret af: AstraZeneca

Bioequivalence Study of ICI176,334-1 in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex 80 mg Tablet -

The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 1

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

20 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Japanese healthy male subjects aged 20 to 45 years
  • Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product
  • Have a body mass index (BMI) between 17 and 27 kg/m2
  • Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s)

Exclusion Criteria:

  • Presence of any disease under medical treatment
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s)
  • Presence of any infectious disease, such as bacteria, virus and fungus
  • Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment
  • Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active 1
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Medicin: ICI176,334-1
Forsøgspersonen vil modtage en enkelt dosis af ICI176,334-1
Medicin: Casodex 80 mg tablet
Forsøgspersonen vil modtage en enkelt dosis af Casodex 80 mg tablet
Eksperimentel: Active 2
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Medicin: ICI176,334-1
Forsøgspersonen vil modtage en enkelt dosis af ICI176,334-1
Medicin: Casodex 80 mg tablet
Forsøgspersonen vil modtage en enkelt dosis af Casodex 80 mg tablet
Eksperimentel: Active 3
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Medicin: ICI176,334-1
Forsøgspersonen vil modtage en enkelt dosis af ICI176,334-1
Medicin: Casodex 80 mg tablet
Forsøgspersonen vil modtage en enkelt dosis af Casodex 80 mg tablet
Eksperimentel: Active 4
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Medicin: ICI176,334-1
Forsøgspersonen vil modtage en enkelt dosis af ICI176,334-1
Medicin: Casodex 80 mg tablet
Forsøgspersonen vil modtage en enkelt dosis af Casodex 80 mg tablet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax)
Tidsramme: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of time to Cmax (tmax)
Tidsramme: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of area under the plasma concentration curve (AUC)
Tidsramme: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 of bicalutamide
Tidsramme: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period

Sekundære resultatmål

Resultatmål
Tidsramme
To assess the safety by assessment of adverse event
Tidsramme: Screening day up to 35 to 42 days (follow-up)
Screening day up to 35 to 42 days (follow-up)
To assess the safety by assessment of vital signs
Tidsramme: Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
To assess the safety by assessment of electrocardiograms (ECGs)
Tidsramme: Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

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. august 2011

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

11. august 2011

Først indsendt, der opfyldte QC-kriterier

11. august 2011

Først opslået (Skøn)

12. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. maj 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2012

Sidst verificeret

1. maj 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D6874L00025

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 ICI176,334-1

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Oman

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner