Safety and Blood Level Study of Unit Dose Budesonide

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose

• Registration Number: NCT00627679
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2005-12
• Study Completion: 2006-05
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-03
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2013-08-19
• Results First Posted: 2013-10-23
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence: A, B, D, C	Budesonide Inhalation Suspension	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 sequence: A, B, D, C	MAP0010 low dose	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 sequence: A, B, D, C	MAP0010 intermediate dose	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 sequence: A, B, D, C	MAP0010 high dose	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 sequence: B, C, A, D	Budesonide Inhalation Suspension	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 sequence: B, C, A, D	MAP0010 low dose	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 sequence: B, C, A, D	MAP0010 intermediate dose	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 sequence: B, C, A, D	MAP0010 high dose	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 sequence: C, D, B, A	Budesonide Inhalation Suspension	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 sequence: C, D, B, A	MAP0010 low dose	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 sequence: C, D, B, A	MAP0010 intermediate dose	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 sequence: C, D, B, A	MAP0010 high dose	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 sequence: D, A, C, B	Budesonide Inhalation Suspension	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 sequence: D, A, C, B	MAP0010 low dose	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 sequence: D, A, C, B	MAP0010 intermediate dose	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 sequence: D, A, C, B	MAP0010 high dose	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

Primary Outcome Measures

Name	Time	Method
Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010	8 hours	The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010	8 hours	Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010	8 hours	The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg\*min/ml).
AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010	8 hours	The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).
Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010	8 hours	Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).

Trial Locations

Locations (1)

Q-Pharm Pty Limited; 🇦🇺 Brisbane, Queensland, Australia