To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on
computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized
objective measure of attention, accuracy and reaction time in healthy naval flight personnel.
Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks)
mean change from baseline in total number of errors (commission errors + omission errors)
between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also
will be assessed.
Minimum age: 18 Years.
Maximum age: N/A.
- Male or female naval flight personnel, ≥18 years of age
- CogScreen-AE Logistic Regression Probability Value < 0. 6 at the baseline screening
- Normal SaO2 (>95%) as measured by pulse oximetry
- Female subjects must be of nonchildbearing potential (i. e., surgically sterile or at
least 1 year postmenopausal); see Section 4. 4 for additional information:
- Female subjects who are pregnant, lactating, or likely to become pregnant during the
- Signs or symptoms of currently active allergic disease (seasonal allergic rhinitis,
perennial allergic rhinitis, episodic allergic rhinitis) within 2 weeks prior to the
- Upper respiratory tract infection, sinusitis, asthma exacerbation, or flu-like
symptoms within 2 weeks prior to the screening visit
- Medical history or physical examination findings; clinically significant
cardiovascular, respiratory, hepatic, neurologic, endocrine, psychiatric, or other
major systemic disease; or laboratory or electrocardiograph abnormality making
implementation of the protocol or interpretation of the protocol results difficult.
Abnormalities which are not clinically significant will not necessarily disqualify
subjects provided, in the opinion of the investigator and sponsor, the study validity
or the subject's welfare is not compromised.
- Any unusual sleep pattern, including third-shift workers (11: 00 PM to 7: 00 AM), or
sleep < 6 hours the night before each AVT testing at Visits 1-4
- Any excessive amounts of alcohol (no more than two drinks/day on average)
- Any excessive use of caffeine (more than three cups of coffee per day or equivalent)
- Any history of chronic alcohol or mood-altering drug abuse
- Any use of tobacco/nicotine products within 90 days of the screening visit or during
- Any disease state or surgery known to affect the gastrointestinal absorption of drugs
- Mental capacity limited to the extent the subject cannot give legal informed consent
or accurate information regarding efficacy and side effects/tolerance of drug
- Subjects unable to comply with the protocol requirements (must complete a screening
visit and Visits 1-4 within approximately 1-1/2 months)
- Known hypersensitivity to fexofenadine, or the tablet ingredients (croscarmellose
sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch; or the
tablet coating made of hydroxypropyl methylcellulose, iron oxide blends, polyethylene
glycol, povidone, silicone dioxide, and titanium dioxide)
- Known hypersensitivity to cetirizine or the tablet ingredients (lactose, magnesium
stearate, povidone, titanium dioxide, hydroxypropyl methylcellulose, polyethylene
glycol, and corn starch)
- Use of an investigational drug within 30 days prior to Visit 1