Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2014-09-01

Brief Summary

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This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PT010

PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Group Type EXPERIMENTAL

PT009

Intervention Type DRUG

PT009 administered as 2 inhalations

Symbicort Turbohaler

Intervention Type DRUG

Symbicort Turbohaler taken as 2 inhalations

PT009

PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Group Type EXPERIMENTAL

PT010

Intervention Type DRUG

PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Symbicort Turbohaler

Intervention Type DRUG

Symbicort Turbohaler taken as 2 inhalations

Symbicort Turbohaler

Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations

Group Type ACTIVE_COMPARATOR

PT010

Intervention Type DRUG

PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

PT009

Intervention Type DRUG

PT009 administered as 2 inhalations

Interventions

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PT010

PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Intervention Type DRUG

PT009

PT009 administered as 2 inhalations

Intervention Type DRUG

Symbicort Turbohaler

Symbicort Turbohaler taken as 2 inhalations

Intervention Type DRUG

Other Intervention Names

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PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder

Eligibility Criteria

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Inclusion Criteria

* Informed Consent Form (ICF) prior to any study related procedures
* Male and female subjects 18 to 55 years, inclusive
* Good general health
* Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
* Clinical labs within normal ranges or determined to be not clinically significant by the Investigator

Exclusion Criteria

* Pregnancy, nursing female subjects, or subjects trying to conceive
* Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
* History of ECG abnormalities
* Cancer not in complete remission for at least 5 years
* Clinically significant, symptomatic prostatic hypertrophy
* Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
* Clinically significant bladder neck obstruction or urinary retention
* Inadequately treated glaucoma
* History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
* Subjects with pre-existing anemia and/or iron deficiency

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes