NCT02030457

A Study to Investigate the Pharmacokinetics and Safety of Beclomethasone Dipropionate Administered by Breath-Actuated Inhaler and Metered-Dose Inhaler in Healthy Adults

A Randomized, Open-Label, 3-Period Crossover, Single-Dose Clinical Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Beclomethasone Dipropionate (160 and 320 mcg) Delivered Via Breath-Actuated Inhaler (BAI) and Metered-Dose Inhaler (MDI) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designed to compare the systemic exposure of orally inhaled beclomethasone dipropionate inhalation aerosol delivered via BAI to that delivered via MDI.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Beclomethasone dipropionate BAI	Breath Activated Inhaler (BAI)
DRUG	Beclomethasone dipropionate MDI	Metered Dose Inhaler (MDI)

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2014-01-08
• Last updated: 2021-11-09

Locations

1 site across 1 country: United States