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.
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|