Sublingual Nicotine Tablets Compared With Swedish Snus

Status Completed

Clinical Trial Summary

To compare each subject's AUCinf, after administration of one single dose of 6 mg of Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of SS containing 16 mg nicotine.

Clinical Trial Description

Open, randomized, five-way cross-over. Single dose administration. The Nicorette 6 mg sublingual tablets and three strengths of SS are tested. Subjects are 18-50 years old, male/female (non-pregnant), healthy volunteer, using minimum 12 pouches of 1 g portion snus or half a can of loose snus per day. The treatments are given as single doses in randomized order. The subject keeps the sublingual tablets still under the tongue for 30 minutes.

The subject keeps the pouch(es) of snus still between the upper lip and the gum for 30 minutes. Serial blood samples are drawn before, and at regular time intervals up to 6 hours after administration.

Amount of nicotine extracted, plasma nicotine concentration at 30 minutes (C30), Tmax, Cmax, AUCinf and heart rate for each treatment. The AUCinf area is based on plasma data corrected for background nicotine (time zero sample).

Each subject's rating of subjective effects using a Visual Analogue Scale (VAS) on a palm top computer, anchored with "not at all" to "extremely".

VAS scores will be obtained at the plasma concentrations sampling time points up to 30 minutes for:

- craving intensity

- overall "product strength" (head rush, "buzz", "hit", feeling alert)

- increased salivation

- burning sensation in the mouth and/or throat ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Smoking Cessation

Clinical Trial Details

NCT number	NCT01838460
Study type	Interventional
Source	Contract Research Organization el AB
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	May 2012
Completion date	February 2013

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