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

Smoking Cessation Clinical Trial

Official title:

Phase 1, Open-Label, Randomized, Single-Dose, Two-Way Crossover Study To Evaluate The Effect Of Food On The Oral Bioavailability Of A Varenicline Controlled Release Formulation In Healthy Adult Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731562
• Other study ID #: A3051088
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2008
• Last updated: January 7, 2010
• Start date: July 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or female adult smokers

• 18 to 55 years of age

Exclusion Criteria:

• Sensitivity to varenicline

• Illegal drug use

• Pregnant or nursing females

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioavailability
• Pharmacokinetics
• Smoking Cessation

Intervention

Drug:
• Varenicline Tartrate Controlled Release
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions
• Varenicline Tartrate Controlled Release
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	East Grand Forks	Minnesota
United States	Pfizer Investigational Site	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maximum plasma concentration of varenicline		1 day	No
Secondary	Safety measures including adverse events		5 days	Yes

External Links

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