A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers.

Phase 1

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: varenicline tartrate; Drug: varenicline free base

• Registration Number: NCT00661765
• Lead Sponsor: Pfizer

Brief Summary

1. To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system \[TDS (patch)\] compared to varenicline immediate release tablet (CHANTIX®).

2. To evaluate the adhesion of the varenicline Formulation A patch.

3. To evaluate the safety and tolerability of a single application of the varenicline patch and a single oral dose of the varenicline immediate release tablet (CHANTIX®).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-18
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• healthy adult smokers

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Exclusion Criteria

• Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease
• Illegal drug usage

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chantix immediate release tablet formulation	varenicline tartrate	-
Varenicline transdermal delivery system	varenicline free base	-

Primary Outcome Measures

Name	Time	Method
Rating Scale for Adhesive Residue (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin)	24 hours per Arm
Rating Scale for Assessment of Application Site Dermal-Erythema, Edema, and Irritation (assesses skin irritation associated with varenicline transdermal delivery system)	6 days per Arm
Pharmacokinetic endpoints: plasma varenicline area under the curve (AUClast and AUCinf), maximum plasma concentration (Cmax), terminal half-life (t 1/2) and time of maximum plasma concentration (Tmax)	6 days per Arm

Secondary Outcome Measures

Name	Time	Method
Assessment of Adhesidue/Cold Flow Assessment (assesses extent of adhesive residue which remains on the skin at application site as well as the adhesive flow beyond the application site border	24 hours per Arm
Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs	6 days per Arm

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Fargo, North Dakota, United States