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Completed

NCT Number: NCT01537692

Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol

The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

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

  • Informed Consent
  • Male or female subjects 18-45 years of age
  • General good health

Exclusion criteria

  • History of physical findings of nasal pathology (within 60 days prior to Screening Visit)
  • Participation in any investigational drug study 30 days preceding Screening Visit
  • History of respiratory infection/disorder with 28 days preceding Screening Visit

Treatment and study plan

BDP HFA Nasal Aerosol

Drug

BDP HFA Nasal 80mcg

BDP HFA Inhalation Aerosol (QVAR)

Drug

BDP HFA Oral 320mcg

Primary outcomes

  1. Pharmacokinetics

    Time frame: 24 hours post dose

    • Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP
    • Maximum plasma concentration (Cmax) for 17-BMP

Secondary outcomes

  1. Pharmacokinetics

    Time frame: 24 hours post dose

    • Area under the plasma concentration time curve extrapolated to infinity (AUC0-inf), time to mean peak plasma concentration (Tmax), and the terminal elimination half-life (t1/2) for 17-BMP
    • AUClast, AUC0-inf, Cmax, Tmax, t1/2 for BDP

  2. Safety and tolerability of BDP HFA nasal aerosol

    Time frame: 24 hours post dose

    Change from baseline in safety and tolerability endpoints - including Adverse events, changes in vital signs (blood pressure and pulse rate) and ENT exams (every visit) and safety laboratory assessments and physical exams (end of study)

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2012
Registry last updated
Feb 23, 2012

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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