Phase 1
Completed N=16
Safety and Blood Level Study of Unit Dose Budesonide
Source: ClinicalTrials.gov NCT00627679 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 — 303.5; 106.2; 239.9; 434.5 pg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 |
303.5; 106.2; 239.9; 434.5 | — |
| PRIMARY Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 |
9.063; 4.467; 3.125; 3.688 | — |
| PRIMARY AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 |
29040; 3978; 8626; 22130 | — |
| PRIMARY AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 |
31480; 4391; 7842; 25290 | — |
| PRIMARY Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 |
145.4; 73.02; 78.35; 140.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00627679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.