NCT05024747

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

A Randomized, Open Label, Single Center, Single Dose, Two Period, Two Sequence Crossover Bioequivalence Study of 21 mg Nicotine Transdermal Patches (NicoDerm CQ, GSK Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed description

This is a 2-arm, single center, single dose, open-label, randomized, two-sequence, two-period crossover, bioequivalence study in healthy adult smokers that have smoked more than 10 cigarettes per day for 1 year prior to initial dose. Carry-over effects will be avoided by a wash-out interval of at least 2 days (but no more than 4 days) from patch removal in the first treatment period to subsequent patch application. The study will consist of an ambulant screening day within 21 days prior first patch application.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	NicoDerm CQ patch (GSK Dungarvan)	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.
DRUG	NicoDerm CQ (Alza)	A single patch of a NicoDerm CQ (Alza) 21 mg/system of 22 cm\^2 surface area will be placed topically.

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-10-25
• Completion: 2021-10-25
• First posted: 2021-08-27
• Last updated: 2024-03-21
• Results posted: 2024-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study