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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.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2002-11 |
| Completion | 2002-12 |
Conditions
- Allergy
Interventions
- Fexofenadine HCI
Primary outcomes
- Size of change in skin flares from baseline measured at pre-specified times post-dose. — 20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points obtained at Hours 23 and 24.
Countries
United States