NCT01966692 - Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

January 20, 2018

Study Completion Date

January 20, 2018

Conditions

Asthma

Interventions

DRUG

Fluticasone Propionate Formulation 1

Fluticasone Propionate dry powder inhaler Formulation 1

DRUG

Fluticasone Propionate Formulation 2

Fluticasone Propionate dry powder inhaler Formulation 2

DRUG

Fluticasone Propionate Formulation 3

Fluticasone Propionate dry powder inhaler Formulation 3

DRUG

Fluticasone Propionate Formulation 3*

"Fluticasone Propionate dry powder inhaler Formulation 3\*~\*(The asterisk) A different set of capsules from the same batch of formulation 3 is given to the subject to assess the within-subject variability and to ensure that the study is sufficiently powered to show bioequivalence between two replicates of the same formulation."

Trial Locations (1)

32610

University of Florida, Gainesville

All Listed Sponsors

collaborator

Food and Drug Administration (FDA)

FED

lead

University of Florida

OTHER