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.

Study Overview

• Status: Completed
• Conditions: Nasal Congestion
• Intervention / Treatment: Drug: Phenylephrine HCl Extended Release; Drug: Phenylephrine HCl Immediate Release

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phenylephrine HCl Extended Release - Fasted; Single dose phenylephrine HCl extended release tablet administered under fasted conditions on Day 1 in one of four study periods	Drug: Phenylephrine HCl Extended Release; One phenylephrine HCl 30 mg extended release tablet orally
Experimental: Phenylephrine HCl Extended Release - Fed; Single dose phenylephrine HCl extended release tablet administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods	Drug: Phenylephrine HCl Extended Release; One phenylephrine HCl 30 mg extended release tablet orally
Active Comparator: Phenylephrine HCl Immediate Release - Fasted; Three single doses of phenylephrine HCl immediate release tablet four hours apart, with the first dose administered under fasted conditions on Day 1 in one of four study periods	Drug: Phenylephrine HCl Immediate Release; One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
Active Comparator: Phenylephrine HCl Immediate Release - Fed; Three single doses of phenylephrine HCl immediate release tablet four hours apart, with the first dose administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods	Drug: Phenylephrine HCl Immediate Release; One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration (Cmax) of phenylephrine	0 hours to time of maximum observed plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment)
Time to Cmax (Tmax) of phenylephrine	0 hours to time of maximum observed plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment)
Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC[0-t])	0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment)
Area under the concentration versus time curve from time 0 to infinity (AUC[0-∞])	0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment)
Terminal rate constant (λz)	0 hours to time of last measurable plasma concentration of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment)
Terminal elimination half-life (t1/2)	0 hours to t1/2 of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 13, 2011
• First Submitted That Met QC Criteria: May 13, 2011
• First Posted (Estimate): May 16, 2011

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: 18124; CL2010-18 (Other Identifier: Protocol Number); P08340 (Other Identifier: Merck)