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

NCT01354418 | Completed Phase 1

• 3 other identifiers: 18124CL2010-18P08340
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Nasal Congestion

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (4)

Phenylephrine HCl Extended Release - Fasted

EXPERIMENTAL

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

Phenylephrine HCl Extended Release - Fed

EXPERIMENTAL

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

Phenylephrine HCl Immediate Release - Fasted

ACTIVE COMPARATOR

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

Phenylephrine HCl Immediate Release - Fed

ACTIVE COMPARATOR

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

Interventions

Phenylephrine HCl Extended Release DRUG

One phenylephrine HCl 30 mg extended release tablet orally

Phenylephrine HCl Extended Release - Fasted; Phenylephrine HCl Extended Release - Fed

Phenylephrine HCl Immediate Release DRUG

One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses

Phenylephrine HCl Immediate Release - Fasted; Phenylephrine HCl Immediate Release - Fed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 16, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 23, 2015

Record last verified: 2015-02