NCT02671825

A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects

A Phase 1 Single Center, Single Group, 7-way Crossover Pilot Pharmacokinetic Study to Evaluate the Disposition of Active Component Following Single Inhaled Doses of Five Formulations of PUR0200 Compared to Reference Product in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Pulmatrix Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare drug blood levels of multiple formulations of inhaled PUR0200 to each other and to the reference product with and without oral charcoal.

Detailed description

The purpose of this study is to compare 5 different formulations of PUR0200 to the reference product. All formulations will be inhaled. In 6 of the 7 study periods either PUR0200 or the reference product will be inhaled under fasting conditions without oral charcoal. In the 7th study period, half of the subjects will receive reference with oral charcoal and the other half will receive reference product without oral charcoal.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PUR0200	PUR0200 dry powder inhalation
DRUG	Reference Product	Dry Powder Inhalation Reference Product

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-02-02
• Last updated: 2016-11-11

Locations

1 site across 1 country: Bulgaria