Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450262
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
Bioequivalence Study to Compare Empagliflozin Metformin HCl 125mg1000mg Film-coated Tablets
Sponsor:
Humanis Saglık Anonim Sirketi
Organization:
Humanis Saglık Anonim Sirketi
Study Overview
Official Title:
Randomized Two-way Two-period Single Oral Dose Open-label Crossover Bioequivalence Study to Compare Empagliflozin Metformin HCl 125mg1000mg Film-coated Tablets 125mg Empagliflozin 1000mg Metformin HCl Versus Synjardy 125mg1000mg Film-coated Tablets 125mg Empagliflozin 1000mg Metformin HCl in Healthy Subjects Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Randomized two-way two-period single oral dose open-label crossover bioequivalence study to compare Empagliflozin Metformin HCl 125mg1000mg film-coated tablets 125mg Empagliflozin 1000mg Metformin HCl versus Synjardy 125mg1000mg film-coated tablets 125mg Empagliflozin 1000mg Metformin HCl in healthy subjects under fed conditions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None