A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Smoking

Treatments: Drug: nicotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01702519

RH01418

Details and patient eligibility

About

Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.

Enrollment: 40 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 19-27 kg/m2
• smokes >10 cigarettes per day for preceeding 6 months

Exclusion criteria

• inability to stop smoking during study

Trial design

40 participants in 2 patient groups

Reference

Active Comparator group

Description:

nicotine transdermal patch with the existing polyisobutylene adhesive

Treatment:

Drug: nicotine

Treatement

Active Comparator group

Description:

nicotine transdermal patch with the alternate polyisobutylene adhesive

Treatment:

Drug: nicotine