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

Bayer

Status and phase: Completed; Phase 1

Conditions: Nasal Congestion

Treatments: Drug: Phenylephrine HCl Extended Release; Drug: Phenylephrine HCl Immediate Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01354418

18124

P08340 (Other Identifier)

CL2010-18 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Phenylephrine HCl Extended Release - Fasted

Experimental group

Description:

Single dose phenylephrine HCl extended release tablet administered under fasted conditions on Day 1 in one of four study periods

Treatment:

Drug: Phenylephrine HCl Extended Release

Phenylephrine HCl Extended Release - Fed

Experimental group

Description:

Single dose phenylephrine HCl extended release tablet administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods

Treatment:

Drug: Phenylephrine HCl Extended Release

Phenylephrine HCl Immediate Release - Fasted

Active Comparator group

Description:

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

Treatment:

Drug: Phenylephrine HCl Immediate Release

Phenylephrine HCl Immediate Release - Fed

Active Comparator group

Description:

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

Treatment:

Drug: Phenylephrine HCl Immediate Release