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.
|ClinicalTrials.gov Identifier: NCT00661765|
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : April 23, 2009
- To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system [TDS (patch)] compared to varenicline immediate release tablet (CHANTIX®).
- To evaluate the adhesion of the varenicline Formulation A patch.
- 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®).
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: varenicline tartrate Drug: varenicline free base||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
|Active Comparator: Chantix immediate release tablet formulation||
Drug: varenicline tartrate
Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
Other Name: varenicline, Chantix, Champix
|Experimental: Varenicline transdermal delivery system||
Drug: varenicline free base
A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.
Other Name: varenicline
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs [ Time Frame: 6 days per Arm ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661765
|United States, North Dakota|
|Pfizer Investigational Site|
|Fargo, North Dakota, United States, 58104|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|