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

Nasal Congestion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354418
• Other study ID #: 18124
• Secondary ID: CL2010-18P08340
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2011
• Last updated: February 20, 2015
• Start date: May 2011
• Est. completion date: July 2011

Study information

• Verified date: February 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Congestion

Intervention

Drug:
• Phenylephrine HCl Extended Release
One phenylephrine HCl 30 mg extended release tablet orally
• Phenylephrine HCl Immediate Release
One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	Area under the concentration versus time curve from time 0 to infinity (AUC[0-8])		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)	No
Primary	Terminal rate constant (?z)		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)	No
Primary	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)	No