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

Healthy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02671825
Study type Interventional
Source Pulmatrix Inc.
Contact
Status Completed
Phase Phase 1
Start date January 2016
Completion date March 2016
View Details
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