A Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Healthy Adult Smokers

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02688374
• Date of registration: 18/02/2016
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Healthy Adult Smokers
• Scientific title: A Single-Dose, Open-Label, Three-way Crossover Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Chinese Male Healthy Adult Smokers
• Date of first enrolment: March 11, 2016
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02688374
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants must understand and provide written informed consent before any
assessment is performed, understand the study procedures, and be willing to complete
the required assessments and the study.

- Chinese male participants between 18 and 45 years of age (inclusive) in general good
physical health as judged by the Investigator.

- Normal vital signs as follows:

- Oral body temperature between 35.0 and 37.5 ºC (95 and 99.5 F) inclusive

- Supine systolic blood pressure between 90 and 140 mmHg inclusive

- Supine diastolic blood pressure between 55 and 90 mmHg inclusive

- Pulse rate between 50 and 100 beats per minute (bpm) inclusive

- History of cigarette smoking of at least 10 cigarettes per day continuously for the
past 3 months prior to screening.

- Body weight = 50 kg, Body Mass Index (BMI) between 19 and 28 at screening.

- Ability to communicate and comply with all study requirements including the study
specific chewing and swallowing procedures.

Exclusion Criteria:-

- Use of other investigational drugs within 30 days or 10 half-lives of enrollment,
whichever is longer.

- History of or known hypersensitivity to the study drug or excipients.

- Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.

- Any surgical or medical condition which may significantly alter the absorption,
distribution, metabolism or excretion of any drug substance.

- History of malignancy or neoplastic disease of any organ system treated or untreated,
orthostatic hypotension, cardiovascular disease, stroke, TIA, fainting or blackouts,
clinically significant metabolic, pulmonary, neurological, hematological, autoimmune,
psychiatric or endocrine disorders.. within the past 5 years prior to screening.

- Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal,
hematological, endocrinological, metabolic, autoimmune, neurological, psychiatric,
other diseases or other clinically significant laboratory findings at screening.

- Participant has used any medication within two weeks before first scheduled study drug
administration or within less than 10 times the elimination half-life of the
respective drug.

- Unable to comply with the chewing and/or swallowing rhythm requirements (> 5%
deviation of the total counts over 30 minutes) after trying either one of the two
training sessions for 3 times.

- CO > 12 ppm after at least 38 hours confinement period in clinics prior to first
dosing.

- Participants reports consumption of any drug metabolizing enzyme inducing or
inhibiting aliments, evidence of current alcohol abuse or reports consumption
exceeding 35 g of pure alcohol per day.

- Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic
diathesis, positive results in any of the virology tests for Human immunodeficiency
virus (HIV)-Ab, Hepatitis C virus (HCV)-Ab, Surface antigen of the hepatitis B virus
(HBs-Ag), and Tp-Ab.

- Participation in a previous clinical study with or without another investigational
product and with ~470 ml blood drawn, or blood donation within the last 3 months prior
to screening or previous enrollment into the current study.

- Vulnerable individual

- Inability to be venipuncture and/or tolerate venous access, unwilling to accept slight
irritation of the throat and increased salivation due to nicotine gum administration.

- Unable or unwilling to discontinue the use or consumption of cigarette smoking, any
nicotine containing products, Oral, local or topical pharmaceutical agents,
consumption of caffeine/theophylline - containing products, grapefruit, Seville
orange, orange, lemon, lime, apple, and pineapple, performance of unaccustomed
strenuous physical exercise.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Tobacco Use Disorder

Intervention(s)

Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum

Other: Treatment A: Nicorette 2 mg coated mint gum

Other: Treatment B: Nicotinell 2 mg coated mint gum

Primary Outcome(s)

Maximum plasma concentration (Cmax) [Time Frame: 2 days]

Area under the curve from time zero to last sampling time [AUC(0-t)] [Time Frame: 2 days]

Area under the curve from time zero extrapolated to infinity [AUC(0-inf)] [Time Frame: 2 days]

Systemic clearance (CL/F) [Time Frame: 2 days]

Termination rate constant (Lambda_z) [Time Frame: 2 days]

Time to reach maximum plasma concentration (Tmax) [Time Frame: 2 days]

Elimination half life (t1/2) [Time Frame: 2 days]

Apparent volume of distribution (Vd/F) [Time Frame: 2 days]

Secondary ID(s)

204979

Source(s) of Monetary Support

Please refer to primary and secondary sponsors