Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025214
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-29
Brief Title:
Bioequivalence Study for Fluticasone Propionate 500 mcgSalmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Sponsor:
Respirent Pharmaceuticals Co Ltd
Organization:
Respirent Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Randomized Single-dose Open Label Two-treatment Two-sequence Two-period Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation PowderRespirent Pharmaceuticals vs ADVAIR DISKUS 50050 Inhalation PowderGSK in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2023-08
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:
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Detailed Description:
A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 500 mcg and Salmeterol xinafoate 50 mcg inhalation powderRespirent Pharmaceuticals test-Τ as 2 inhalations and ADVAIR DISKUS 50050 mcg inhalation powderGSK reference-R in healthy volunteers under fasting conditions The study will be one-center crossover randomized 2-period 2-sequence RT and TR single dose laboratory-blinded
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?:
True
Is an FDA AA801 Violation?:
None