Study identifier:D5985C00001
ClinicalTrials.gov identifier:NCT04600505
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Single blind, 3-Period, 3-Treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of BGF Propellant 1 and BGF Propellant 2 Compared with BGF MDI HFA in Healthy Subjects
Chronic obstructive pulmonary disease (COPD)
Phase 1
Yes
Treatment A, Treatment A, Treatment A, Treatment A, Treatment A, Treatment A, Treatment B, Treatment B, Treatment B, Treatment B, Treatment B, Treatment B, Treatment C, Treatment C, Treatment C, Treatment C, Treatment C, Treatment C
Male
47
Interventional
18 Years - 60 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2022 by AstraZeneca
AstraZeneca
Parexel International
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment Sequence ABC Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment B; Treatment C) in 3 treatment periods, with first dose on Day -1 for all treatment periods. | Drug: Treatment A Participants will receive 2 inhalations of BGF MDI with propellant 1. Other Name: BGF MDI Propellant 1 Drug: Treatment B Participants will receive 2 inhalations of BGF MDI with propellant 2. Other Name: BGF MDI Propellant 2 Drug: Treatment C Participants will receive 2 inhalations of BGF MDI with HFA propellant. Other Name: BGF MDI HFA |
Experimental: Treatment Sequence BCA Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment B; Treatment C; Treatment A) in 3 treatment periods, with first dose on Day -1 for all treatment periods. | Drug: Treatment A Participants will receive 2 inhalations of BGF MDI with propellant 1. Other Name: BGF MDI Propellant 1 Drug: Treatment B Participants will receive 2 inhalations of BGF MDI with propellant 2. Other Name: BGF MDI Propellant 2 Drug: Treatment C Participants will receive 2 inhalations of BGF MDI with HFA propellant. Other Name: BGF MDI HFA |
Experimental: Treatment Sequence CAB Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment C; Treatment A; Treatment B) in 3 treatment periods, with first dose on Day -1 for all treatment periods. | Drug: Treatment A Participants will receive 2 inhalations of BGF MDI with propellant 1. Other Name: BGF MDI Propellant 1 Drug: Treatment B Participants will receive 2 inhalations of BGF MDI with propellant 2. Other Name: BGF MDI Propellant 2 Drug: Treatment C Participants will receive 2 inhalations of BGF MDI with HFA propellant. Other Name: BGF MDI HFA |
Experimental: Treatment Sequence ACB Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment C; Treatment B) in 3 treatment periods, with first dose on Day -1 for all treatment periods. | Drug: Treatment A Participants will receive 2 inhalations of BGF MDI with propellant 1. Other Name: BGF MDI Propellant 1 Drug: Treatment B Participants will receive 2 inhalations of BGF MDI with propellant 2. Other Name: BGF MDI Propellant 2 Drug: Treatment C Participants will receive 2 inhalations of BGF MDI with HFA propellant. Other Name: BGF MDI HFA |
Experimental: Treatment Sequence BAC Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment B; Treatment A; Treatment C) in 3 treatment periods, with first dose on Day -1 for all treatment periods. | Drug: Treatment A Participants will receive 2 inhalations of BGF MDI with propellant 1. Other Name: BGF MDI Propellant 1 Drug: Treatment B Participants will receive 2 inhalations of BGF MDI with propellant 2. Other Name: BGF MDI Propellant 2 Drug: Treatment C Participants will receive 2 inhalations of BGF MDI with HFA propellant. Other Name: BGF MDI HFA |
Experimental: Treatment Sequence CBA Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment C; Treatment B; Treatment A) in 3 treatment periods, with first dose on Day -1 for all treatment periods. | Drug: Treatment A Participants will receive 2 inhalations of BGF MDI with propellant 1. Other Name: BGF MDI Propellant 1 Drug: Treatment B Participants will receive 2 inhalations of BGF MDI with propellant 2. Other Name: BGF MDI Propellant 2 Drug: Treatment C Participants will receive 2 inhalations of BGF MDI with HFA propellant. Other Name: BGF MDI HFA |