Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NicoDerm CQ patch (GSK Dungarvan)
NicoDerm CQ patch · 1 trial · 1 indication
Cmax was the highest observed plasma nicotine concentration of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was reported. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed pharmacokinetic (PK) variables, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
Area under the plasma concentration versus time curve from time zero to time t, where t was the time of the last measurable plasma concentration of nicotine, estimated, computed using the linear trapezoidal rule. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed PK variable, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
Area under the plasma concentration versus time curve calculated from time zero to infinity. AUC0-inf = AUC0-t + C(t)/λz. C(t)- Concentration at the last measurable sampling time point and λz- terminal elimination rate constant. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed PK variable, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.
| Arm | Type | Description |
|---|---|---|
| Test Product | EXPERIMENTAL | Participants will receive a single NicoDerm CQ patch (GSK Dungarvan) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours. |
| Reference Product | ACTIVE_COMPARATOR | Participants will receive a single NicoDerm CQ patch (Alza) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours. |
| Name | Type | Description |
|---|---|---|
| NicoDerm CQ patch (GSK Dungarvan) | DRUG | A single patch of a NicoDerm CQ (GSK Dungarvan) 21 mg per system of 22 centimeter square (cm\^2) surface area will be placed topically. |
| NicoDerm CQ (Alza) | DRUG | A single patch of a NicoDerm CQ (Alza) 21 mg/system of 22 cm\^2 surface area will be placed topically. |
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, ...
NicoDerm CQ patch is a nicotine transdermal patch developed by Haleon plc (ticker HLN) for tobacco use disorder. It is a small molecule therapy in the psychiatry therapeutic area. The product is designed to deliver nicotine through the skin as an aid for smoking cessation in adults.
NicoDerm CQ patch is used for tobacco use disorder, which covers smoking cessation support. The clinical program enrolled healthy adult smokers aged 21 years and older in the United States. The studied condition in its trial was tobacco use disorder.
Haleon plc, which trades under the ticker HLN, is the developer of NicoDerm CQ patch. The bioequivalence trial lists the test product as NicoDerm CQ from GSK Dungarvan, compared against the marketed NicoDerm CQ patch manufactured by Alza.
NicoDerm CQ patch has been studied in a Phase 1 clinical trial, and that trial is completed. The program recorded one total trial with 22 participants, and no trials are currently active. The study was randomized and used an active control.
NicoDerm CQ patch was evaluated in trial NCT05024747, a Phase 1 bioequivalence study of the 21 mg nicotine transdermal patch. The trial compared the GSK Dungarvan patch to the marketed Alza 21 mg patch in healthy adult smokers. It enrolled 22 participants in the United States and is completed.
Yes, NicoDerm CQ patch (GSK Dungarvan) refers to the same product as NicoDerm CQ patch. The parenthetical identifies the GSK Dungarvan manufacturing site used in the bioequivalence study, where it was compared with the marketed NicoDerm CQ patch produced by Alza.