Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-20 @ 1:40 PM
Study NCT ID:
NCT02028767
Status:
COMPLETED
Last Update Posted:
2015-07-24
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Bioequivalence of Empagliflozin/Metformin (12.5mg/500mg) Fixed Dose Combination Tablets Compared to Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open Label, Randomised, Single Dose, Two Period, Two Sequence Crossover Study)
Status:
COMPLETED
Status Verified Date:
2015-06
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:
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: