Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED)
Condition: Blood Pressure; Human Experimentation
Intervention: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg; Placebo
Intervention description: Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.; Placebo taken twice daily (12 hours apart) for 7 days.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized
      on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy
      with randomized active or placebo treatment with a subsequent 6-8 day washout period,
      followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory
      blood pressure measurement will be performed beginning on Day 7 of each treatment period
      following administration of the study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, male or female volunteers must be 18 years or older, with a Body Mass Index
             (BMI) between 19-30 inclusive [BMI = weight (kilograms)/height (meters squared)].

          -  Clinical laboratory tests (complete blood count, blood chemistries, urinalysis), Human
             Immunodeficiency Virus (HIV) antibodies, hepatitis B surface antigen, hepatitis C
             antibody must be within normal limits or clinically acceptable to the
             Investigator/Sponsor.

          -  Drug screen for drugs and alcohol with a high potential for abuse must be negative at
             screening.

          -  Subjects must be free of any clinically significant disease that requires a
             physician's care and/or would interfere with study evaluations, procedures or
             participation.

          -  Subjects must agree not to take a monoamine oxidase inhibitor (MAOI) for two weeks (14
             days) prior to study participation and for two weeks (14 days) after the end of their
             study participation.

          -  Subjects must have normal or clinically acceptable physical exam and Electrocardiogram
             (ECG) intervals (PR, QRS, QT and QTc) on 12-lead ECG (recorded at 25
             millimeters/second [mm/s]).

          -  Subjects must have a mean after 5 minute of rest sitting systolic/diastolic office
             blood pressure ≤ 138/88 millimeters of mercury (mmHg).

          -  Subjects with controlled diabetes prior to entry must have a mean sitting after 5
             minute of rest systolic/diastolic office blood pressure ≤ 128/78 mmHg from
             non-dominated arm

          -  Females must have the urine or serum pregnancy test (Human Chorionic Gonadotropin)
             that is negative at Screening and Day 1 of Period 1.

          -  Female subjects of childbearing potential must be using medically acceptable birth
             control measures.

          -  Subjects must understand the dosing schedule.

          -  Subjects must be able to read and write in English.

        Exclusion Criteria:

          -  Subjects must not have any significant medical condition which, in the judgment of the
             Investigator, is a contraindication to the use of phenylephrine HCl, might interfere
             with the study or requires treatment expected to affect the blood pressure. These may
             include hyperthyroidism, hypothyroidism, uncontrolled diabetes mellitus, coronary
             heart disease, ischemic heart disease, elevated intraocular pressure, prostatic
             hypertrophy.

          -  Subjects who have a history of any clinically significant local or systemic infectious
             disease within four weeks prior to initial treatment administration.

          -  Subjects who have received an investigational drug within 30 days prior to study
             dosing.

          -  Subjects who are, appear to be, or are known, current or former drug addicts or
             alcoholics.

          -  Subjects who are positive for hepatitis B surface antigen or hepatitis C antibody.

          -  Subjects who are positive for HIV antibodies.

          -  Subjects who have a clinically significant history of food or drug allergy.

          -  Subjects who have a known allergy or intolerance to phenylephrine HCl.

          -  Females who are pregnant, nursing or unwilling to use/practice adequate contraception
             (hormonal, Intrauterine Device, barrier method, etc.).

          -  Subjects taking topical or oral decongestant products within 7 days of Visit 2.

          -  Subjects taking antihypertensive medication.

          -  Subjects taking monoamine oxidase inhibitors.

          -  Subjects taking tricyclic antidepressants (e.g. amitriptyline, nortriptyline,
             imipramine)

          -  Subjects taking antithyroid medication (e.g. propylthiouracil, methimazole, iodides).