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.

Smoking Cessation Clinical Trial

Official title:

A Phase I, Open-Label, Randomized, Single Dose, Cross Over Study to Estimate the Relative Bioavailability of a Varenicline (CP-526,555) Transdermal Delivery System to the Chantix Immediate Release Tablet Formulation in Adult Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661765
• Other study ID #: A3051071
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2008
• Last updated: April 22, 2009
• Start date: April 2008
• Est. completion date: June 2008

Study information

• Verified date: April 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy adult smokers

Exclusion Criteria:

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

• Illegal drug usage

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• varenicline tartrate
Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
• varenicline free base
A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating Scale for Adhesive Residue (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin)		24 hours per Arm	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs		6 days per Arm	Yes

External Links

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