Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)

A Randomized Crossover Bioequivalence Study Comparing a Single Dose of Phenylephrine HCl 30 mg Extended Release Tablet to Three Phenylephrine HCl 10 mg Immediate Release Tablets Each Consecutively Dosed Four Hours Apart Under Fed and Fasting Conditions

This study will assess the food-effect bioavailability of an extended release formulation of phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl product.

Inclusion Criteria:

• In good health
• Female participants must not be pregnant
• Agrees to use two acceptable methods of birth control throughout the study
• Agrees not to take monoamine oxidase inhibitor (MAOI) for 2 weeks prior to, during, and 2 weeks after the end of the study

Exclusion Criteria:

• Any significant medical condition which is a contraindication to the use of phenylephrine HCl, might interfere with the study, or requires treatment expected to affect blood pressure
• Any infectious disease within 4 weeks prior to initial treatment administration
• History of malignancy, except basal cell carcinoma
• Cannot comply with requirement to abstain from the use of any drugs (except acetaminophen or herbal/vitamin supplements) within 14 days prior to study and alcohol or xanthine-containing substances (coffee, chocolate) within 72 hours prior to study
• Received an investigational drug within thirty days prior to study drug dosing
• Known or apparent current or former drug addicts or alcoholics
• Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B surface antigen, or hepatitis C antibody
• Cannot accept a high-fat, high-calorie breakfast
• Known allergy or intolerance to phenylephrine HCl
• Have used phenylephrine-containing product within 2 weeks prior to study start
• Have smoked tobacco, used tobacco products, or used a nicotine-containing smoking cessation aid within the past 6 months