NCT03259607 is a Phase 1 clinical trial of Nicorette Extra Mint 2 mg Gum in Tobacco Dependence, sponsored by McNeil AB.

Who is sponsoring NCT03259607?

NCT03259607 is sponsored by McNeil AB.

What drugs are being tested in NCT03259607?

Interventions in NCT03259607: Nicorette Extra Mint 2 mg Gum, Nicorette Mint 2 mg Gum, Nicorette Extra Mint 4mg Gum, Nicorette Mint 4 mg Gum.

What condition does NCT03259607 study?

NCT03259607 studies Tobacco Dependence.

Is NCT03259607 still recruiting?

NCT03259607 is currently completed. Last updated 3 January 2019.

Last reviewed 2019-01-03 · How we verify

NCT03259607

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers

Completed Phase 1 Last updated 3 January 2019

What this trial tests

Phase 1 trial testing Nicorette Extra Mint 2 mg Gum in Tobacco Dependence in 76 participants. Completed in 9 January 2018.

Timeline

14 August 2017

Primary endpoint
25 December 2017

9 January 2018

Quick facts

Lead sponsor	McNeil AB
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	76
Start date	14 August 2017
Primary completion	25 December 2017
Estimated completion	9 January 2018
Sites	1 location across China

Drugs / interventions tested

Nicorette Extra Mint 2 mg Gum — full drug profile →
Nicorette Mint 2 mg Gum — full drug profile →
Nicorette Extra Mint 4mg Gum — full drug profile →
Nicorette Mint 4 mg Gum — full drug profile →

Conditions studied

Tobacco Dependence — all drugs for Tobacco Dependence →

Sponsor

McNeil AB — full company profile →

Who can join

Adults 18 to 55, any sex, with Tobacco Dependence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a research study to verify the same effectiveness and safety profile for the test products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products, Nicorette Mint 2 mg gum and Nicorette Mint 4 mg gum (reference products), in a standardized mode. This verification is done in a so-called bioequivalence study, which means that the same amount of the same active substance (nicotine), in the same dosage form, for the same route of administration, and meeting the same or comparable standards is performed. During the study visits, blood samples will be drawn to measure the level of the substance in the blood to verify that the two test products are comparable to the reference products. Tolerability of the treatments will be evaluated based on reported and observed adverse events.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Tobacco Dependence

Currently open trials in the same condition.

NCT07220356 — C-Raven, a Virtual Tobacco Cessation Intervention in Residency Clinics · Phase 4 · recruiting
NCT07148232 — Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness · Phase 4 · recruiting
NCT06881069 — Reach Through Equitable Implementation in Utah · NA · recruiting
NCT06488443 — Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals · NA · recruiting
NCT06218056 — Cannabidiol for Reducing Cigarette Use · Phase 2 · recruiting

Other McNeil AB trials

Trials by the same sponsor.

NCT05182047 — A Study of Butamirate Citrate Syrup Versus (vs) Sinecod Syrup (Vanilla) in Adult Healthy Study Volunteers · Phase 1 · withdrawn
NCT04186936 — A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Co · Phase 1 · completed
NCT03697889 — A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 2 · Phase 1 · completed
NCT03439436 — A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion. · Phase 3 · completed
NCT03432923 — A Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat. · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03259607 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by McNeil AB
Last refreshed: 3 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03259607.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing