Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290102
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-02-26
Brief Title:
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler Fp MDPI in Children Aged 4 to 11 Years Old
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
An Open Label Single Dose 3-Period Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone PropionateAlbuterol Sulfate FpABS Multidose Dry Powder Inhaler With e-Module eMDPI Compared to Fluticasone Propionate Multidose Dry Powder Inhaler Fp MDPI in Participants With Asthma 4 to 11 Years Old
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are
To determine the pharmacokinetic PK profile of fluticasone propionate Fp and albuterol sulfate ABS delivered in combination from a single dose of TEV-56248 Fp and ABS multidose dry powder inhaler with e-module FpABS eMDPI in participants with asthma
To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler Fp MDPI
To compare the PK profiles of ABS between the 2 different strengths of TEV-56248
The secondary objective is
To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI
To determine the pharmacokinetic PK profile of fluticasone propionate Fp and albuterol sulfate ABS delivered in combination from a single dose of TEV-56248 Fp and ABS multidose dry powder inhaler with e-module FpABS eMDPI in participants with asthma
To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler Fp MDPI
To compare the PK profiles of ABS between the 2 different strengths of TEV-56248
The secondary objective is
To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI
Detailed Description:
The planned duration for this trial is approximately 15 to 3 months The trial includes a 14-day screening period 3 treatment periods 2 days each and a follow up visit 7 days after end of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None