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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01354418
First received: May 13, 2011
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Nasal Congestion
Drug: Phenylephrine HCl Extended Release
Drug: Phenylephrine HCl Immediate Release
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Maximum plasma concentration (Cmax) of phenylephrine [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Time to Cmax (Tmax) of phenylephrine [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC[0-t]) [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Area under the concentration versus time curve from time 0 to infinity (AUC[0-∞]) [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Terminal rate constant (λz) [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t1/2) [ Time Frame: 0 hours to t1/2 of phenylephrine (blood samples will be collected up to 24 hours after first administration of study treatment) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01354418     History of Changes
Other Study ID Numbers: P08340, CL2010-18
Study First Received: May 13, 2011
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014