A Study Evaluating the Absorption of Varenicline Into the Body From a Varenicline Solution Applied to the Skin.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking Cessation
Intervention: Varenicline free base solution (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
To evaluate the absorption, safety, and tolerability of a varenicline solution applied to the
skin.
Clinical Details
Official title: A Phase 1, Open-Label, Nonrandomized, Single Dose Study to Characterize the Pharmacokinetics of a Varenicline (CP-526,555) Solution Applied to the Skin of Adult Smokers
Study design: Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf)
Secondary outcome: Evaluation of adverse events (including skin irritation)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy, adult, smokers
Exclusion Criteria:
- pregnant
- significant medical illness
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2008
Ending date: December 2008
Last updated: October 16, 2008
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