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.

Conditions: Allergy

Summary: 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.


Eligibility criteria:
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.