Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04124094
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2019-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade
Sponsor:
Respirent Pharmaceuticals Co Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study to Examine the Bioequivalence Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. SERETIDE DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers Under Fasting Conditions With Charcoal Blockade
Status:
COMPLETED
Status Verified Date:
2020-07
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 (discus) 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 100 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and SERETIDE DISKUS® 100/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions with charcoal blockade. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: