NCT00627679

Safety and Blood Level Study of Unit Dose Budesonide

A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Budesonide Inhalation Suspension	Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
DRUG	MAP0010 low dose	Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
DRUG	MAP0010 intermediate dose	Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
DRUG	MAP0010 high dose	Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

Timeline

• Start date: 2005-12-01
• Primary completion: 2005-12-01
• Completion: 2006-05-01
• First posted: 2008-03-03
• Last updated: 2014-01-09
• Results posted: 2013-10-23

Locations

1 site across 1 country: Australia