An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation

Phase 1

Completed

• Conditions: Pharmacokinetics; Bioavailability; Smoking Cessation
• Interventions: Drug: Varenicline Tartrate Controlled Release

• Registration Number: NCT00731562
• Lead Sponsor: Pfizer

Brief Summary

1. To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions.

2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-07
• Last Update Posted: 2010-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy male or female adult smokers
• 18 to 55 years of age

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Exclusion Criteria

• Sensitivity to varenicline
• Illegal drug use
• Pregnant or nursing females

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Varenicline Controlled Release, Fed	Varenicline Tartrate Controlled Release	-
Varenicline Controlled Release, Fasted	Varenicline Tartrate Controlled Release	-

Primary Outcome Measures

Name	Time	Method
Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf).	5 days
Maximum plasma concentration of varenicline	1 day

Secondary Outcome Measures

Name	Time	Method
Safety measures including adverse events	5 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Fargo, North Dakota, United States