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Completed

NCT Number: NCT01354418

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

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.

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Key information

Conditions

Nasal Congestion Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine HCl Extended Release

Drug

One phenylephrine HCl 30 mg extended release tablet orally

Phenylephrine HCl Immediate Release

Drug

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 16, 2011
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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