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Study Reference No. - C1D00695

Demographic Gender Age Location Compensation
In general good health; non-smokers for at least the past 1 year Males or Females 18-55 Mississauga, ON $2,030
Study Details

Study Purpose

The purpose of this study is to compare and evaluate bioavailability of Albuterol Sulfate Inhalation Aerosol 90 mcg per actuation manufactured by Amneal Ireland Limited, Ireland with PROAIRĀ® HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation in healthy, adult, human subjects under fasting conditions.

Study Duration

Approximately 10 days from Period 1 Check-in until the last blood sample collection of the study.

Study Schedule

General Screening

NA

Medical Screening

April 5, 7, 8 , 10, 12

Study Visit(s)

COHORT 1 Technique training (2 hrs) Check-in (PM) Check Out (AM) 36 hr Return (PM)
Period 1 19-Apr-21 20-Apr-21 22-Apr-21 22-Apr-21
Period 2 N/A 27-Apr-21 29-Apr-21 29-Apr-21
COHORT 2 Technique training (2 hrs) Check-in (PM) Check Out (AM) 36 hr Return (PM)
Period 1 21-Apr-21 22-Apr-21 24-Apr-21 24-Apr-21
Period 2 N/A 29-Apr-21 01-May-21 01-May-21

Follow-Up Visit(s)

NA

Other Notes

Bring Valid Photo ID.

COVID-19 test will be conducted prior to each Period check-in.