A Phase 2 interventional study of A006 DPI and A006 DPI in Asthma, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-19.
Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 22 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Amphastar Pharmaceuticals, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One inhalation of 110 mcg A006 DPI. Total 110 mcg
Drug: A006 DPI
One inhalation of 220 mcg A006 DPI. Total 220 mcg.
Drug: A006 DPI
One inhalation of 90 mcg Proventil® MDI. Total 90 mcg.
Drug: Proventil® MDI
Two inhalations of 90 mcg Proventil® MDI. Total 180 mcg
Drug: Proventil® MDI
Single dose 110 mcg, 1 inhalation
Also known as: Albuterol, Albuterol DPI
Single dose 220 mcg, 1 inhalation
Also known as: Albuterol, Albuterol DPI
Single dose 90 mcg, 1 inhalation
Also known as: Proventil®
Single dose 90 mcg, 2 inhalations
Also known as: Proventil®
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
Systolic Blood Pressure (SBP) at Screening
Subjects will have their vital signs, i.e., blood pressure and heart rate, measured during the Screening Visit to ensure they are generally healthy.
Time frame: Within 14 days prior to Day 1 (Visit 1)
Systolic Blood Pressure (SBP)
Subject will have their vital signs, i.e., blood pressure and heart rate, measured prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Diastolic Blood Pressure (DBP) at Screening
Subjects will have their vital signs, i.e., blood pressure and heart rate, measured during the Screening Visit to ensure they are generally healthy.
Time frame: Within 14 days prior to Day 1 (Visit 1)
Diastolic Blood Pressure (DBP)
Subject will have their vital signs, i.e., blood pressure and heart rate, measured prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Heart Rate (HR) at Screening
Subjects will have their vital signs, i.e., blood pressure and heart rate, measured during the Screening Visit to ensure they are generally healthy.
Time frame: Within 14 days prior to Day 1 (Visit 1)
Heart Rate (HR)
Subject will have their vital signs, i.e., blood pressure and heart rate, measured prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
12-Lead ECG QT Intervals at Screening
12-Lead ECGs will be performed to measure QT and QTc intervals during the Screening Visit to ensure absence of overt cardiac illnesses.
Time frame: Within 14 days prior to Day 1 (Visit 1)
12-Lead ECG QT Intervals
12-Lead ECGs will be performed to measure QT and QTc intervals prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
12-Lead ECG QTc Intervals at Screening
12-Lead ECGs will be performed to measure QT and QTc intervals during the Screening Visit to ensure absence of overt cardiac illnesses.
Time frame: Within 14 days prior to Day 1 (Visit 1)
12-Lead ECG QTc Intervals
12-Lead ECGs will be performed to measure QT and QTc intervals prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period.
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Complete Blood Count (CBC) at Screening
A CBC will be performed as part of the subject safety evaluations at screening.
Time frame: Within 14 days prior to Day 1 (Visit 1)
Complete Blood Count (CBC) at End-of-Study
A CBC will be performed as part of the End-of-Study subject safety evaluations at end-of-study.
Time frame: 4 hours post-dose at Visit 4 (within 6 weeks after Day 1 (Visit 1))
Comprehensive Metabolic Panel (CMP) at Screening
A CMP will be performed as part of the subject safety evaluations at screening.
Time frame: Within 14 days prior to Day 1 (Visit 1)
Comprehensive Metabolic Panel (CMP) at End-of-Study
A CMP will be performed as part of the End-of-Study subject safety evaluations at end-of-study.
Time frame: 4 hours post-dose at Visit 4 (within 6 weeks after Day 1 (Visit 1))
Urinalysis at Screening
Routine and microscopic urinalysis will be performed as part of the subject safety evaluations at screening.
Time frame: Within 14 days prior to Day 1 (Visit 1)
Urinalysis at End-of-Study
Routine and microscopic urinalysis will be performed as part of the End-of-Study subject safety evaluations at end-of-study.
Time frame: 4 hours post-dose at Visit 4 (within 6 weeks after Day 1 (Visit 1))
Incidents of Pregnancy at Screening
A urinary pregnancy test will be performed for women of child-bearing potential as a part of the Screening Visit evaluations to determine the eligibility of the subject for the study.
Time frame: Within 14 days prior to Day 1 (Visit 1)
Incidents of Pregnancy at End-of-Study
A urinary pregnancy test will be performed for women of child-bearing potential as a part of the End-of-Study safety evaluations to determine if a pregnancy had occurred during the study.
Time frame: 4 hours post-dose at Visit 4 (within 6 weeks after Day 1 (Visit 1))
Serious Adverse Events
Adverse drug events (ADEs), whether observed by investigators or reported by the subjects, will be documented, evaluated, followed up, and treated if deemed necessary. According to FDA guidelines, a serious ADE will refer to any adverse drug experience occurring at any dose that results in any of the following outcomes: 1) death; 2) a life-threatening adverse drug experience; 3) inpatient hospitalization or prolongation of existing hospitalization; 4) persistent or significant disability/incapacity; 5) congenital anomaly/birth defect; 6) other important medical events that may jeopardize the subject or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. ADEs will be followed until stabilized/resolved or 30 days from the date the subject has finished the study, whichever is sooner.
Time frame: Signing of Informed Consent at Screening Visit to End-of-Study Visit, an expected average of 7 Weeks
Other Adverse Events
Adverse drug events (ADEs), whether observed by investigators or reported by the subjects, will be documented, evaluated, followed up, and treated if deemed necessary. ADEs will be followed until stabilized/resolved or 30 days from the date the subject has finished the study, whichever is sooner.
Time frame: Signing of Informed Consent at Screening Visit to End-of-Study Visit, an expected average of 7 Weeks
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Amphastar Pharmaceuticals, Inc.