Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.
Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.
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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  Asthma that required treatment with medication other than an inhaled, short-acting
 beta agonist

 -  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
 (rush) immunotherapy

 -  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
 entry

 -  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

 -  Pregnancy

 -  Breast-feeding

 -  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
 results difficult

 -  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,
 rectal)(30 days).

 -  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,
 antipsychotics)(14 days).

 -  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.