The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220 mcg (T2), in healthy male and female adult volunteers.
This study is a randomized, double or evaluator-blinded, single dose, four-arm, crossover PK study in eighteen (18) healthy volunteers, both male and female adults, at 18-40 years of age. All candidates will be screened and only those who satisfy all enrollment criteria will be enrolled into this study. Each study subject will participate in a screening visit and four (4) study visits with one (1) randomized study treatment given in each visit. PK samples will be analyzed with an established LC/MS/MS method. An End-of-Study (EOS) safety evaluation will be conducted at the end of Study Visit-4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Single dose 110 mcg, 1 inhalation
Single dose 220 mcg, 1 inhalation
Single dose 90 mcg, 1 inhalation
Amphastar Site 0035
Cypress, California, United States
Area Under the Curve of Drug Concentration versus Time (AUC[0-t])
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Area under the curve of the drug concentration versus time curve (AUC\[0-t\]) for each treatment period will be calculated using the trapezoidal rule.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Peak Plasma Concentration (C[max])
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Peak plasma concentration (C\[max\]) will be the highest concentration of Albuterol during each treatment period.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Time to Reach Peak Plasma Concentration (t[max])
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Time to reach peak plasma concentration (t\[max\]) will be the time it takes to reach the highest concentration of Albuterol during each treatment period.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Plasma Albuterol Concentrations at All Time Points
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Plasma Albuterol concentrations at these time points will be reported during each treatment period.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
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Single dose 90 mcg, 2 inhalations