Conditions: Blood Pressure Human Experimentation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 116
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Phenylephrine HCl Extended Release tablets 30 mg arm 2: Placebo

Interventions: intervention 1: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days. intervention 2: Placebo taken twice daily (12 hours apart) for 7 days.

Protocol document: