Viewing Study NCT06450262



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