Expired Study
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Fargo, North Dakota 58104


Purpose:

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®).


Criteria:

Inclusion Criteria: - healthy adult smokers Exclusion Criteria: - Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease - Illegal drug usage


Study is Available At:


Original ID:

A3051071


NCT ID:

NCT00661765


Secondary ID:


Study Acronym:


Brief Title:

A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:April 2008
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:April 2009
Last Changed Date:April 22, 2009
First Received Date:April 14, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Rating Scale for Adhesive Residue (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin)
Time Frame:24 hours per Arm
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Rating Scale for Assessment of Application Site Dermal-Erythema, Edema, and Irritation (assesses skin irritation associated with varenicline transdermal delivery system)
Time Frame:6 days per Arm
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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)
Time Frame:6 days per Arm
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Time Frame:24 hours per Arm
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs
Time Frame:6 days per Arm
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:varenicline tartrate
Description:Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
Arm Name:Chantix immediate release tablet formulation
Other Name:varenicline, Chantix, Champix
Intervention Type:Drug
Name:varenicline free base
Description:A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.
Arm Name:Varenicline transdermal delivery system
Other Name:varenicline

Study Arms

Study Arm Type:Experimental
Arm Name:Varenicline transdermal delivery system
Study Arm Type:Active Comparator
Arm Name:Chantix immediate release tablet formulation

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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