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A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days

NCT01234142 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-10-14

No results posted yet for this study

Summary

This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.

Conditions

  • Smoking Cessation

Interventions

DRUG

varenicline free base patch

varenicline transdermal delivery system (12.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days

DRUG

varenicline free base patch

varenicline transdermal delivery system (18.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days

DRUG

placebo patch

Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days

DRUG

varenicline free base patch

varenicline transdermal delivery system (24.0 mg payload \[drug amount loaded in each patch\]) will be applied to the skin once daily for 14 days

DRUG

placebo patch

Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days

DRUG

varenicline free base patch

2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days

DRUG

placebo patch

Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01234142 on ClinicalTrials.gov