Safety and Blood Level Study of Unit Dose Budesonide

Asthma Clinical Trial

— UDB P101  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627679
• Other study ID #: MAP0010-CL-P101
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2008
• Last updated: December 9, 2013
• Start date: December 2005
• Est. completion date: May 2006

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Limited	Brisbane	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
Allergan	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan, Q-Pharm Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010	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).	8 hours	No
Primary	Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010	Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).	8 hours	No
Primary	AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010	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).	8 hours	No
Primary	AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010	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).	8 hours	No
Primary	Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010	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).	8 hours	No