Pharmacokinetic Study of 4 mg Nicotine Lozenge.
12. januar 2015 oppdatert av: GlaxoSmithKline
A Randomized, Cross-Over, Single Dose Pharmacokinetic Study of 4mg Nicotine Lozenges.
This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge.
Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Gujarat
-
Ahmedabad, Gujarat, India, 380 061
- Lambda Therapeutic Research Ltd
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.
Exclusion Criteria:
- inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Prototype 1
4mg nicotine lozenge administered orally as a single dose treatment per subject
|
4 mg nicotine lozenge experimental
|
|
Eksperimentell: Prototype 2
4mg nicotine lozenge administered orally as a single dose treatment per subject
|
4 mg nicotine lozenge experimental
|
|
Eksperimentell: Prototype 3
4mg nicotine lozenge administered orally as a single dose treatment per subject
|
4 mg nicotine lozenge experimental
|
|
Aktiv komparator: Reference Therapy
4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject.
|
4 mg nicotine lozenge experimental
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Curve From Time 0 to t, AUC (0-t)
Tidsramme: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine.
AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
|
Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
|
Maximum Plasma Concentration (Cmax)
Tidsramme: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
Maximum plasma nicotine concentration was determined from plasma-concentration time profiles.
Cmax was based on the baseline adjusted nicotine plasma concentration data.
|
Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
AUC(0-inf)
Tidsramme: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
Area under the plasma nicotine concentration-time curve from zero extrapolated to infinity was determined.
AUC(0-inf) was based on the baseline adjusted nicotine plasma concentration data.
|
Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
|
Time to Maximum Plasma Concentration (Tmax)
Tidsramme: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
Tmax was determined from plasma concentration time profiles.
Tmax was based on the baseline adjusted nicotine plasma concentration data.
|
Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
|
Rate of Elimination (Kel)
Tidsramme: Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
Elimination rate constant for nicotine was calculated.
Kel was based on the baseline adjusted nicotine plasma concentration data.
|
Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
|
Plasma Half Life (t1/2)
Tidsramme: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
Half-life of elimination of nicotine was determined.
t1/2 was based on the baseline adjusted nicotine plasma concentration data.
|
Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2012
Primær fullføring (Faktiske)
1. august 2012
Studiet fullført (Faktiske)
1. august 2012
Datoer for studieregistrering
Først innsendt
16. august 2012
Først innsendt som oppfylte QC-kriteriene
16. august 2012
Først lagt ut (Anslag)
20. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. januar 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. januar 2015
Sist bekreftet
1. oktober 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RH01333
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .