Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)

Inclusion Criteria

• •Healthy male or female volunteers must be 18 years or older.
• •Participants must be willing to stop use of current decongestant and allergy medications during the study, and at the start of the run-in period (Visit 2).
• •Participants must have a documented history of allergic rhinitis caused by ragweed allergen for at least the prior two years.
• •Participants must have a documented skin testing (prick with wheal \>= 3 mm larger than the diluent or intradermal with wheal \>=7 mm larger than the diluent control) or a positive in vitro test for specific IgE to the ragweed allergen within the last four years.
• •Participants must have signs by clinical evaluation and symptoms of nasal congestion of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) at Visit 3 following the run-in period and at visit 5 following the washout period.
• •Clinical laboratory tests (complete hematology, blood chemistries, urinalysis) must be within normal limits or clinically acceptable to the Investigator/Sponsor. Sponsor will not grant waivers.
• •Participants must have a seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤ 138/88 mmHg.
• •Participants must have normal or clinically acceptable physical exam and electrocardiogram (ECG) on 12-lead ECG (recorded at 25 mm/s).
• •Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures or participation.
• •Participants must agree not to take monoamine oxidase inhibitor (MAOI) for 14 days before study participation and 14 days after the end of the study.
• •Participants must be willing to give written informed consent (prior to any study related procedures being performed) and able to adhere to restrictions and examination schedules.
• •Female participants of childbearing potential (a non-menopausal female who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure, including a young woman who has not yet started menstruating) must be using medically acceptable (documented failure rate of less than 1%) birth control measures. Examples of medically acceptable contraception include hormonal contraceptives, intrauterine device (IUD), double-barrier method (any combination of male or female condom, diaphragm, spermicidal gel, sponge) or sterilization.
• •Participants must be able to read and write English, and must understand the dosing schedule.