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Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

6. juli 2012 opdateret af: McNeil AB

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Sverige
      • Lund, Sverige, SE-222 20
        • McNeil AB Clinical Pharmacology R&D

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

19 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.
  • BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
  • Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
  • A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
  • Willing and able to comply with all scheduled visits and study procedures

Exclusion Criteria:

  • Pregnancy, lactation or intended pregnancy.
  • Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
  • Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.

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: NRT 60
A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits
Medicin: Nicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
Andre navne:
  • Endnu ikke markedsført
Medicin: Nicotine
4 mg marketed Nicotine Fruit Gum (NFG)
Andre navne:
  • Nicorette® Freshfruit Gum
Medicin: Nicotine
4 mg marketed nicotine mint lozenge (NIQ)
Andre navne:
  • NiQuitinTM Mint lozenge
Aktiv komparator: NFG 60
A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits
Medicin: Nicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
Andre navne:
  • Endnu ikke markedsført
Medicin: Nicotine
4 mg marketed Nicotine Fruit Gum (NFG)
Andre navne:
  • Nicorette® Freshfruit Gum
Medicin: Nicotine
4 mg marketed nicotine mint lozenge (NIQ)
Andre navne:
  • NiQuitinTM Mint lozenge
Eksperimentel: NRT 90
A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits
Medicin: Nicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
Andre navne:
  • Endnu ikke markedsført
Medicin: Nicotine
4 mg marketed Nicotine Fruit Gum (NFG)
Andre navne:
  • Nicorette® Freshfruit Gum
Medicin: Nicotine
4 mg marketed nicotine mint lozenge (NIQ)
Andre navne:
  • NiQuitinTM Mint lozenge
Aktiv komparator: NFG 90
A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits
Medicin: Nicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
Andre navne:
  • Endnu ikke markedsført
Medicin: Nicotine
4 mg marketed Nicotine Fruit Gum (NFG)
Andre navne:
  • Nicorette® Freshfruit Gum
Medicin: Nicotine
4 mg marketed nicotine mint lozenge (NIQ)
Andre navne:
  • NiQuitinTM Mint lozenge
Aktiv komparator: NIQ 60
A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits
Medicin: Nicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
Andre navne:
  • Endnu ikke markedsført
Medicin: Nicotine
4 mg marketed Nicotine Fruit Gum (NFG)
Andre navne:
  • Nicorette® Freshfruit Gum
Medicin: Nicotine
4 mg marketed nicotine mint lozenge (NIQ)
Andre navne:
  • NiQuitinTM Mint lozenge

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Observed Plasma Concentration
Tidsramme: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
within the last dosing interval (starting at 10.5-11 hours after first product administration)
Average Concentration
Tidsramme: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Average Nicotine Plasma Concentration (Cav) within the last dosing interval
within the last dosing interval (starting at 10.5-11 hours after first product administration)
Area Under the Curve
Tidsramme: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)
within the last dosing interval (starting at 10.5-11 hours after first product administration)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tid for maksimal koncentration
Tidsramme: I løbet af 12 timer efter dosis
Det tidspunkt, hvor maksimal koncentration nås (Tmax)
I løbet af 12 timer efter dosis
Minimum Observed Concentration
Tidsramme: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Minimum Observed Plasma Concentration (Cmin), which is the minimum concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
within the last dosing interval (starting at 10.5-11 hours after first product administration)
Peak-Trough Fluctuation
Tidsramme: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Percent of Peak-Trough Fluctuation in one dosing interval at steady state (PTF)
within the last dosing interval (starting at 10.5-11 hours after first product administration)
Swing
Tidsramme: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Swing in one dosing interval at steady state, calculated as (Cmax-Cmin)/ Cmin
within the last dosing interval (starting at 10.5-11 hours after first product administration)
Nicotine Released
Tidsramme: 30 minutes
The amount of nicotine released from the product during product administration
30 minutes

Samarbejdspartnere og efterforskere

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

Sponsor

McNeil AB

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. februar 2011

Primær færdiggørelse (Faktiske)

1. maj 2011

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

22. marts 2011

Først indsendt, der opfyldte QC-kriterier

23. marts 2011

Først opslået (Skøn)

24. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NICTDP1081
  • 2010-023026-20 (EudraCT nummer)

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 Nicotine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malaysia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner