Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA
Primatene Mist HFA · 1 trial · 1 indication
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...