Trials / Completed
CompletedNCT02189304
Pharmacokinetics and Safety Study of PT010 in Healthy Subjects
A Phase I, Randomized, Double-Blind, Single-Dose, Three-Period, Three-Treatment, Cross-Over Study Evaluating the Pharmacokinetics and Safety of a Single Dose of PT010, a Single Dose of PT009, and a Single Dose of Open-Label Symbicort® Turbohaler® in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Pearl Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PT010 | PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations |
| DRUG | PT009 | PT009 administered as 2 inhalations |
| DRUG | Symbicort Turbohaler | Symbicort Turbohaler taken as 2 inhalations |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2014-07-14
- Last updated
- 2018-06-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02189304. Inclusion in this directory is not an endorsement.