Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01189201
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2010-08-25
Brief Title:
Rel BA of Empagliflozin BI 10773Linagliptin FDC Tbl Comparison With Mono-components With a Second FDC Tablet and Influence of Food
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Relative Bioavailability Investigations of a 25 mg BI 10773 5 mg Linagliptin Fixed Dose Combination FDC Tablet Formulation A1 Including the Comparison With Its Mono-components the Comparison With a Second FDC Tablet Formulation A3 and the Investigation of Food an Open-label Randomised Single Dose Crossover Phase I Trial in Healthy Male and Female Volunteers
Status:
COMPLETED
Status Verified Date:
2015-03
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 primary objective of the current study is to investigate the relative bioavailability of BI 10773 linagliptin fixed dose combination tablet formulation A1 Treatment A Test compared to BI 10773 given in free combination with linagliptin Treatment B Reference both in the fasting state All 42 subjects entered are planned to be included in this comparison
The secondary objective is to investigate the relative bioavailability of BI 10773 linagliptin fixed dose combination tablet after administration of a standardised high fat high caloric meal formulation A1 Treatment C Test compared to BI 10773 linagliptin fixed dose combination in the fasting state formulation A1Treatment A Reference Of the 42 subjects entered 18 subjects are planned to be included in this comparison
An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 linagliptin formulation A3Treatment D Test compared to BI 10773 linagliptin fixed dose combination tablet formulation A1Treatment A Reference Of the 42 subjects entered 24 subjects are planned to be included in this comparison
The secondary objective is to investigate the relative bioavailability of BI 10773 linagliptin fixed dose combination tablet after administration of a standardised high fat high caloric meal formulation A1 Treatment C Test compared to BI 10773 linagliptin fixed dose combination in the fasting state formulation A1Treatment A Reference Of the 42 subjects entered 18 subjects are planned to be included in this comparison
An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 linagliptin formulation A3Treatment D Test compared to BI 10773 linagliptin fixed dose combination tablet formulation A1Treatment A Reference Of the 42 subjects entered 24 subjects are planned to be included in this comparison
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-019211-38 | EUDRACT_NUMBER | EudraCT | None |