Compare the effect of a single dose of fexofenadine HCl 180 mg plus orange juice versus
placebo plus orange juice on the change from baseline (pre-dose) in histamine skin flares.
- Healthy male or non-pregnant, non-lactating female subjects; 12-55 years of age;
within 15% of normal body weight for their height or had a body mass index (BMI) less
than 29.9 kg/m2; positive histamine skin prick tests (or a duplicate histamine skin
prick test) of summation flare > 20 mm larger than diluent control, and summation
wheal > 6 mm larger than diluent control at the screening Visit 1.
- Asthma that required treatment with medication other than an inhaled, short-acting
- Signs and symptoms of currently active allergic disease (SAR, perennial allergic
rhinitis, episodic allergic rhinitis)
- Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2
weeks prior to Visit 1
- Dermatographism or other skin conditions that might interfere with the interpretation
of the skin test results
- Treatment with escalating doses of immunotherapy, oral immunotherapy, or short course
- Any excessive amounts of alcohol (no more than two drinks/day on average)
- Any excessive use of caffeine (more than six 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 visit 1
- Any disease state or surgery known to affect the gastrointestinal absorption of drugs
- Treatment with an H1-receptor antagonist regularly within the past year before study
- Known hypersensitivity to the investigational product or to drugs with similar
chemical properties, or to orange juice
- Need to visit a tanning salon during the study
- Need to use artificial tanning products during the study
- Likelihood of requiring treatment during the study period with drugs not permitted by
the clinical study protocol (see Section 6.2)
- Treatment with any investigational product in the last 30 days before study entry
- Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major
systemic disease making implementation of the protocol or interpretation of the study
- Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study
- Unlikelihood of complying with protocol, e.g., uncooperative attitude, inability to
return for follow-up visits, and unlikelihood of completing the study.
- Use of any of the following drugs within the time indicated prior to the first dosing
visit (Time prior to Visit 2):
- Systemic or injected corticosteroids (including oral, parenteral, intravenous,
- Nasal or inhaled or ocular corticosteroids (30 days).
- Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal,
inhaled, or ophthalmic sodium cromolyn (14 days)
- Agents with antihistaminic/anticholinergic activity (e.g.antidepressants,
- Leukotriene pathway modifiers (Accolate®, Singulair®, Zyflo®) 10 days Ocular
anti-allergy medications including lodoxamide (Alomide®), olopatadine (Patanol®),
emedastine difumarate (Emadine®), levocabastine (Livostin®) (10 days).
- Non-steroidal anti-inflammatory ophthalmics including ketorolac (Acular®),
flurbiprofen (Ocufen®), suprofen (Profenal®), diclofenac (Voltaren®) (10 days).
- Antihistamines including desloratadine (Clarinex®), loratadine (Claritin®)(10 days).
- Fexofenadine HCl (Allegra®), cetirizine (Zyrtec®), hydroxyzine, azelastine nasal
spray (Astelin®), clemastine (7 days)
- Other short-acting antihistamines such as chlorpheniramine or drugs with
antihistaminic activity (3 days).
- OTC oral antihistamines, decongestants (includes pseudoephedrine and other
decongestants), or antihistamines/decongestant combinations including all cold,
cough, and sleep aids (3 days).
- OTC ophthalmic decongestant, antihistamine, or decongestant/ antihistamine
combinations (3 days).
- Other anticholinergic agents (3 days).
- Immunotherapy injection (1 day).
- Other drugs were to be permitted if they were not expected to interfere with the
ability of the subject to participate in the study.
- Non-steroidal anti-inflammatory agents were not allowed for 2 days prior to each
treatment visit day through 24 hours post-dose.
- Medications or agents not specified above that might confound the interpretation of
the results were prohibited as follows:
- Caffeine within 6 hours prior to each visit (coffee, tea, cola, including Mountain
Dew and Surge).
- Decaffeinated coffee, tea and colas within 6 hours of each visit
- Alcohol within 24 hours prior to each study visit.
- Chocolate within 6 hours prior to each visit.
- Antacids within + 2 hours of investigational product dosing.
- Any waiver of these inclusion and exclusion criteria required approval by the
investigator and the sponsor on a case-by-case basis prior to enrolling the subject.
Approval had to be documented by both the sponsor and the investigator.
- No subject was to be allowed to enroll in this study more than once.