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

NCT03259607 | Completed Phase 1

• 2 other identifiers: CO-160307090208-SCCT10258820NIK1001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Dependence

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax) of nicotine.

  The maximum observed plasma concentration (Cmax).

  At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

• Area under the plasma concentration versus time curve (AUCt) from start of nicotine administration until the last measurable concentration.

  AUCt is defined as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.

  At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

• Area under the plasma concentration versus time curve (AUC∞) of nicotine.

  AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the nicotine plasma concentration is negligible (infinity).

  At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

Secondary Outcomes (14)

• The extrapolated part of area under the plasma concentration versus time curve (AUC∞) of nicotine.

  Extrapolation from 12 hours after start of drug administration until 48 hours.

• The time at which the maximum nicotine concentration (Cmax) occurs (Tmax).

  At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

• Determination of the terminal elimination rate constant (lambda_z) for nicotine.

  At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

• The plasma half-life (t1/2) of nicotine.

  At baseline, 5, 10, 15, 20, 30, 45, and 60 minutes, as well as 1.5, 2, 4, 6, 7, 8, 9, and 10 hours after start of administration.

• Amount of nicotine extracted from Nicorette Mint 2 mg gums.

  After 30 minutes of chewing.

Study Arms (4)

Treatment A

EXPERIMENTAL

Nicorette Extra Mint 2 mg Gum

Drug: Nicorette Extra Mint 2 mg Gum

Treatment B

ACTIVE COMPARATOR

Nicorette Mint 2 mg Gum

Drug: Nicorette Mint 2 mg Gum

Treatment C

EXPERIMENTAL

Nicorette Extra Mint 4 mg Gum

Drug: Nicorette Extra Mint 4mg Gum

Treatment D

ACTIVE COMPARATOR

Nicorette Mint 4 mg Gum

Drug: Nicorette Mint 4 mg Gum

Interventions

Nicorette Extra Mint 2 mg Gum DRUG

A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

Treatment A

Nicorette Mint 2 mg Gum DRUG

A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

Treatment B

Nicorette Extra Mint 4mg Gum DRUG

A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

Treatment C

Nicorette Mint 4 mg Gum DRUG

A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.

Treatment D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects between the ages of 18 and 55 years, inclusive, and healthy female subjects between the ages of 18 and 45 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram (ECG) as well as clinical laboratory tests, as judged by the Investigator or an authorized physician.
• Subjects will have a body mass index (BMI) between 19 and 25 (inclusive) kg/m2 and a body weight \>50 kg.
• Females of childbearing potential must have a negative pregnancy test at the screening visit.
• Male or non-pregnant, non-lactating female agree to the contraceptive requirements including male's and female partner's use of a highly effective methods of birth control for at least 3 months before the study, during the study and for 30 days after the last dose of the study drug).
• A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study before participating in any study-specific procedures.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.

You may not qualify if:

• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, Human Immunodeficiency Virus (HIV) or syphilis.
• Hypersensitivity to the ingredients/components of any of the IPs.
• History of alcoholism, as judged by the Investigator, within the past 6 months preceding this study and/or presenting a positive respiratory alcohol test (breathalyzer) at the screening visit.
• History of drug abuse or presenting a positive drug screening test for psychoactive drugs and narcotic substances at screening visit.
• Treatment with an IP within 3 months preceding this study.
• Donation or loss of blood within 3 months preceding this study if the estimated lost blood volume equaled or exceeded 200 mL.
• Impaired chewing capability as assessed by oral examination (e.g. dentures, significant oral ulceration) or impaired salivary secretion (e.g. Sicca syndrome). Piercing of tongue and lips is considered to impair oral function.
• Preplanned surgery or procedures during the study period, if this may interfere with the conduct of the study.
• Relationship to persons involved directly with the conduct of the study (i.e. PI; Sub investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson (J\&J) subsidiaries; and the families of each).

Sponsors & Collaborators

• McNeil AB: lead
• Janssen (China) Research & Development Center: collaborator

Study Sites (1)

Beijing Hospital, No.1

Beijing, 100730, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shi Aixin, M. Pharm

  BeiJing Hospital, No.1, Beijing, China.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, randomized, single-dose, open-label, cross-over study

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 23, 2017
• Study Start: August 14, 2017
• Primary Completion: December 25, 2017
• Study Completion: January 9, 2018
• Last Updated: January 3, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)