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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Oxymetazoline; Phenylephrine

Criteria

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