Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01255709 | Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS | PHASE2 | COMPLETED | 24 | — | — | Dec 1, 2010 | Jan 1, 2011 | Mar 17, 2016 | 1 | United States |
Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3. * Mean Maximum concentration of epinephrine (Cmax for epinephrine) * Mean Area Under the Curve (AUC) for epinephrine * Time to maximum concentration (tmax) and Half life of the drug (t1/2) * Epinephrine concentrations versus time
| Arm | Type | Description |
|---|---|---|
| Arm T1 Primatene Mist HFA | EXPERIMENTAL | epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes |
| Arm C Primatene Mist | ACTIVE_COMPARATOR | epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes |
| Arm T2 Primatene Mist HFA | EXPERIMENTAL | epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes |
| Name | Type | Description |
|---|---|---|
| Arm T1: Primatene Mist HFA | DRUG | epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes |
| Arm T2: Primatene Mist HFA | DRUG | epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes |
| Arm C: Primatene Mist (epinephrine inhalation aerosol, USP) | DRUG | epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes |
Inclusion Criteria: * Generally healthy at screening; * Body weight ≥ 50 kg for men and ≥ 45 kg for women; * Sitting blood pressure ≤ 135/90 mmHg; * Demonstrating negative hIV, HBsAG and DCV-Ab screen tests; * Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a cl...