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

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Phenylephrine HCl Extended Release - Fasted	Phenylephrine HCl Extended Release	Single dose phenylephrine HCl extended release tablet administered under fasted conditions on Day 1 in one of four study periods
Phenylephrine HCl Extended Release - Fed	Phenylephrine HCl Extended Release	Single dose phenylephrine HCl extended release tablet administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods
Phenylephrine HCl Immediate Release - Fed	Phenylephrine HCl Immediate Release	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
Phenylephrine HCl Immediate Release - Fasted	Phenylephrine HCl Immediate Release	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

Primary Outcome Measures

Name	Time	Method
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)
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 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)

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility