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

NCT02030457 Phase 1 COMPLETED

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

Details

Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	72
Start date	2013-12
Completion	2014-06

Conditions

• Pharmacokinetics

Interventions

• Beclomethasone dipropionate BAI
• Beclomethasone dipropionate MDI

Primary outcomes

• Area under the plasma drug concentration-time (AUC0-t) — Baseline, up to 24 hours
  At each treatment period
• Maximum observed plasma drug concentration (Cmax) — Baseline, up to 24 hours
  At each treatment period

Countries

United States