Mode
Text Size
Log in / Sign up
Phase 1 Completed N=21 Randomized Other

A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers

Source: ClinicalTrials.gov NCT05024747 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Maximum Observed Plasma Nicotine Concentration (Cmax) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference) — 23.554; 24.478 Nanograms per milliliter (ng/mL)

Summary

The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently manufactured by Alza (Reference).

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Observed Plasma Nicotine Concentration (Cmax) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)
23.554; 24.478
PRIMARY
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t]) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)
529.464; 564.085
PRIMARY
Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity (AUC [(0-inf]) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)
537.518; 571.211
SECONDARY
Terminal Elimination Rate Constant (Lambda z) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) of Patches
0.2141; 0.2475 0.0833
SECONDARY
Maximum Plasma Nicotine Concentration (Tmax) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
4.000; 18.000 0.0205 sig
SECONDARY
Elimination Half-Life (t1/2) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
3.2376; 2.8001 0.0946
SECONDARY
Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches
16; 20; 0; 0; 0; 0
SECONDARY
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (TEAEs)
7; 11; 0; 0

Eligibility Criteria

Inclusion Criteria

  • Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Participant is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, as determined by medical evaluation, including a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) or clinical laboratory tests.
  • Body Mass Index (BMI) of 19 to 27 kilogram/meter Squared (kg/m^2); and a total body weight >50 kg (110 Pound-Mass [lbs]).
  • Any female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female participant who are not of childbearing potential must meet requirements of protocol.
  • Participants admits to having smoked more than 10 cigarettes per day for the preceding one year (prior to initial dose).
  • Participant with two negative tests (one at screening and one at check in Day-2) for active COVID-19, separated by > 24 hours.

Exclusion Criteria

  • A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK Consumer Health (CH) employee directly involved in the conduct of the study or a member of their immediate family.
  • A participant who has participated in other studies (including non-medicinal studies) involving any investigational product(s) within 30 days before first dosing.
  • A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • A Participant who is pregnant as confirmed by a positive serum pregnancy test or intending to become pregnant over the duration of the study.
  • A participant who is breastfeeding.
  • A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients ethylene vinyl acetatecopolymer, polyisobutylene and high density polyethylene.
  • Diagnosis of long QT syndrome or corrected QT (QTc) > 450 Millisecond (msec) for a male participant and > 470 msec for a female participant at screening.
  • A participant unwilling or unable to comply with Lifestyle Considerations described in this protocol.
  • Participant is unwilling to abstain from tobacco or nicotine-containing product use during the study (from check-in to the completion of the last pharmacokinetics (PK) blood sampling). Expired carbon monoxide (CO) measurement immediately prior to randomization (first treatment session) and dosing (second treatment session) should be less than or equal to ( =1.4 milligram per deciliter [mg/dL]) or Blood urea nitrogen (BUN) (>=25 mg/dL) or the presence of clinically significant abnormal urinary constituents (e.g.

albuminuria);

  • History or current evidence of ongoing hepatic disease or impaired hepatic function at screening. A candidate will be excluded if more than one of the following lab value deviations are found: 1) Aspartate transaminase/Serum glutamic oxaloacetic transaminase (AST/SGOT) (>= 1.2 upper limit of normal [ULN]), Alanine transaminase/Serum glutamic pyruvic transaminase (ALT/S
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05024747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search