Title
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
Phase
Phase 1Lead Sponsor
AllerganStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
AsthmaIntervention/Treatment
budesonide ...Study Participants
16The 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.
Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
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.
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.
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.
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 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 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 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
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
| Event Type | Organ System | Event Term | Treatment A | Treatment B | Treatment C | Treatment D |
|---|
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 is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
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).
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) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).
