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.

NCT00661765 | Completed Phase 1

• 1 other identifier: A3051071
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system \[TDS (patch)\] compared to varenicline immediate release tablet (CHANTIX®).
2. 2.To evaluate the adhesion of the varenicline Formulation A patch.
3. 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®).

Conditions

Smoking Cessation

Keywords

varenicline bioavailability transdermal smoking cessation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (2)

Chantix immediate release tablet formulation

ACTIVE COMPARATOR

Drug: varenicline tartrate

Varenicline transdermal delivery system

EXPERIMENTAL

Drug: varenicline free base

Interventions

varenicline tartrate DRUG

Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation

Also known as: varenicline, Chantix, Champix

Chantix immediate release tablet formulation

varenicline free base DRUG

A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.

Also known as: varenicline

Varenicline transdermal delivery system

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adult smokers

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Fargo, North Dakota, 58104, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 18, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 23, 2009

Record last verified: 2009-04

Locations

US (1)