NCT00627679 - Safety and Blood Level Study of Unit Dose Budesonide | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

December 31, 2005

Study Completion Date

May 31, 2006

Conditions

Asthma

Interventions

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.

Trial Locations (1)

QLD 4006

Q-Pharm Pty Limited, Brisbane