NCT02815644

Brief Summary

The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (FDC) tablet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

July 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 16, 2018

Completed
Last Updated

August 16, 2018

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

June 24, 2016

Results QC Date

September 18, 2017

Last Update Submit

October 5, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Cmax for Linagliptin

    Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin

    2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

  • Cmax for Empagliflozin

    Maximum measured concentration of the analyte in plasma (Cmax) for empagliflozin

    2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

  • AUC 0-tz for Linagliptin

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for linagliptin

    2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

  • AUC 0-tz for Empagliflozin

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for empagliflozin

    2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

Secondary Outcomes (3)

  • AUC0-infinity for Linagliptin

    2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

  • AUC0-infinity for Empagliflozin

    2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

  • AUC0-72 for Linagliptin

    2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.

Study Arms (1)

empagliflozin/linagliptin FDC

EXPERIMENTAL

empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet

Drug: empagliflozin/linagliptin FDC

Interventions

empagliflozin/linagliptin FDCDRUG

empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet

empagliflozin/linagliptin FDC

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects age \>=20 and \<=45 years; body weight: \>=50 kg and \<=80 kg; body mass index: \>=18.0 and \<=25.0 kg/m2
  • Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)
  • Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

  • Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 133-0004, Japan

Location

MeSH Terms

Interventions

empagliflozin

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 28, 2016

Study Start

July 15, 2016

Primary Completion

October 5, 2016

Study Completion

October 5, 2016

Last Updated

August 16, 2018

Results First Posted

August 16, 2018

Record last verified: 2017-10

Locations

JP(1)