Safety and Blood Level Study of Unit Dose Budesonide

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allergan
• Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan; Q-Pharm Pty Limited
• Treatments: Budesonide

Criteria

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