Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum
This study has been completed.
Sponsor:
McNeil AB
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT01113424
First received: April 28, 2010
Last updated: July 6, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Bioequivalence between oral nicotine replacement products and Nicorette® gum.
| Condition | Intervention |
|---|---|
|
Tobacco Dependence |
Drug: Nicotine Drug: Nicorette® (Nicotine Gum) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bioequivalence Between Oral Nicotine Replacement Products and Nicorette® Gum - A Study in Healthy Smokers |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Primary Outcome Measures:
- Pharmacokinetic measurements [ Time Frame: Baseline and during 10 hours after product administration ] [ Designated as safety issue: No ]
Pharmacokinetic measurements including:
- the maximum observed nicotine concentration in plasma (Cmax)
- the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)
- the area under the plasma concentration-vs.-time curve until infinity (AUCinf)
Secondary Outcome Measures:
- Tmax [ Time Frame: during 10 hours after start of product administration ] [ Designated as safety issue: No ]The time of occurrence of Cmax (tmax) following product administration
- λz [ Time Frame: during 10 hours after start of product administration ] [ Designated as safety issue: No ]The terminal nicotine elimination rate constant (λz)
- Residual Nicotine [ Time Frame: After 30 minutes of chewing ] [ Designated as safety issue: No ]The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing.
- Dissolution Time [ Time Frame: From product administration until completely dissolved ] [ Designated as safety issue: No ]Actual time required for oral dissolution of new NRT products following product administration
| Enrollment: | 88 |
| Study Start Date: | September 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NRT-2
2 mg single-dose of a new NRT product
|
Drug: Nicotine
Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
Other Name: Not yet marketed
|
|
Active Comparator: GUM-2
2 mg single-dose of a marketed nicotine gum
|
Drug: Nicorette® (Nicotine Gum)
Single-dose of marketed nicotine gum 2 mg or 4 mg
Other Name: Nicorette®
|
|
Experimental: NRT-4
4 mg single-dose of a new NRT product
|
Drug: Nicotine
Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
Other Name: Not yet marketed
|
|
Active Comparator: GUM-4
4 mg single-dose of marketed nicotine gum
|
Drug: Nicorette® (Nicotine Gum)
Single-dose of marketed nicotine gum 2 mg or 4 mg
Other Name: Nicorette®
|
Detailed Description:
This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
- Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion Criteria:
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB ) |
| ClinicalTrials.gov Identifier: | NCT01113424 History of Changes |
| Other Study ID Numbers: | NICTDP1071, 2008-003358-14 |
| Study First Received: | April 28, 2010 |
| Last Updated: | July 6, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
|
Smoking Cessation Nicotine pharmacokinetics |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013