Safety and Blood Level Study of Unit Dose Budesonide (UDB P101)

Allergan

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: Budesonide Inhalation Suspension; Drug: MAP0010 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627679

MAP0010-CL-P101

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult volunteers, aged 18-50 years
• BMI less than 30 kg/m2
• Non smoker (currently and <10 pack years total if ex-smoker)

Exclusion criteria

• Any use of corticosteroid in previous 4 weeks
• Pregnancy/lactation
• Significant blood donation (or testing) in previous 8 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 4 patient groups

Treatment sequence: A, B, D, C

Experimental group

Description:

Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5

Treatment:

Drug: MAP0010 high dose

Drug: MAP0010 low dose

Drug: MAP0010 intermediate dose

Drug: Budesonide Inhalation Suspension

Treatment sequence: B, C, A, D

Experimental group

Description:

Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5

Treatment:

Drug: MAP0010 high dose

Drug: MAP0010 low dose

Drug: MAP0010 intermediate dose

Drug: Budesonide Inhalation Suspension

Treatment sequence: C, D, B, A

Experimental group

Description:

Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5

Treatment:

Drug: MAP0010 high dose

Drug: MAP0010 low dose

Drug: MAP0010 intermediate dose

Drug: Budesonide Inhalation Suspension

Treatment sequence: D, A, C, B

Experimental group

Description:

Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5

Treatment:

Drug: MAP0010 high dose

Drug: MAP0010 low dose

Drug: MAP0010 intermediate dose

Drug: Budesonide Inhalation Suspension