A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin

Phase 1

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Varenicline free base solution; Drug: Varenicline free base patch

• Registration Number: NCT00774605
• Lead Sponsor: Pfizer

Brief Summary

To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.

Detailed Description

Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline solution and a varenicline patch applied to the skin

Study Timeline

• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Study Start: 2008-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-22
• Last Update Posted: 2009-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• healthy, adult, male smokers

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Exclusion Criteria

• significant medical illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline free base solution	Varenicline free base solution	-
Varenicline transdermal delivery system	Varenicline free base patch	-

Primary Outcome Measures

Name	Time	Method
Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf)	8 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of adverse events (including skin irritation)	8 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States