Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: PT010 (BGF MDI) 320/14.4/9.6 µg; PT010 (BGF MDI) 160/14.4/9.6 µg; PT003 (GFF MDI) 14.4/9.6 µg
Intervention description: A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.; A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.; A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
Intervention MeSH terms: Budesonide; Glycopyrrolate; Formoterol Fumarate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of
      PT003 in healthy Chinese adult subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female Chinese subjects 18-45 years of age

          -  Females of childbearing potential must agree to be abstinent or else use one of the
             medically acceptable forms of contraception A female whose male partner has had a
             vasectomy must agree to use one additional form of medically acceptable contraception.

        A male subject with female partner of child bearing potential must agree to use one
        additional form of medically acceptable contraception

        -Be in good general health as assessed at Screening and have no clinically significant
        abnormal labs at Screening.

        Exclusion Criteria:

          -  Pregnant or nursing female subjects or subjects who are trying to conceive

          -  Subjects with clinically significant neurologic, cardiovascular, hepatic, renal,
             endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that
             would interfere with participation in this study

          -  Subjects with a history of ECG abnormalities

          -  Subjects who have cancer that has not been in complete remission for at least 5 years

          -  Male subjects with symptomatic prostatic hypertrophy that is clinically significant in
             the opinion of the Investigator

          -  Male subjects with a trans-urethral resection of the prostate or full resection of the
             prostate within 6 months prior to Screening

          -  Males with bladder neck obstruction or urinary retention that is clinically
             significant in the opinion of the Investigator

          -  Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not
             been adequately treated

          -  History of substance-related disorders within 1 year of Screening

          -  History of smoking or the use of nicotine containing products or electronic cigarettes
             within 3 months of Screening by self-reporting

          -  A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the
             Screening Visit or at the beginning of each inpatient period

          -  Treatment with any prescription or non-prescription drugs (including vitamins, herbal,
             and dietary supplements) within 30 days

          -  Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen
             (HbsAg) or positive hepatitis C antibody at Screening

          -  Positive for Syphilis Antibody

          -  Subjects with any flu-like syndrome or other respiratory infections

          -  Recently vaccinated with an attenuated live virus