NCT01284621

Brief Summary

Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if ramipril affects the pharmacokinetics of BI 10773.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 healthy

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

Study Start

First participant enrolled

January 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

January 20, 2011

Results QC Date

May 16, 2014

Last Update Submit

June 23, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • Total Empa: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss)

    Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of empagliflozin (empa).

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Total Empa: Maximum Measured Concentration (Cmax,ss)

    Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of empagliflozin (empa).

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Total Ramipril: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).

    Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramipril.

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Total Ramipril: Maximum Measured Concentration (Cmax,ss)

    Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramipril.

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Total Ramiprilat: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).

    Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramiprilat (active metabolite of ramipril).

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Total Ramiprilat: Maximum Measured Concentration (Cmax,ss)

    Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramiprilat.

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

Secondary Outcomes (9)

  • Empa: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Ramiprilat: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Time From Last Dosing to the Maximum Measured Concentration (Tmax,ss)

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Terminal Rate Constant (λz,ss)

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • Terminal Half-life (T 1/2,ss)

    0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4

  • +4 more secondary outcomes

Study Arms (3)

BI 10773

EXPERIMENTAL

1 tablet per days for 5 days, oral administration with 240 mL water for each treatment

Drug: BI 10773

Ramipril

OTHER

1 tablet on day 1 and 2 tablets per day on day 2-5, oral administration with 240 mL water for each treatment

Drug: Ramipril

BI 10773 + Ramipril

OTHER

1 tablet BI 10773 and 1 tablet on day 1 and 2 tablets ramipril per day on day 2-5, oral administration with 240 mL water for each treatment

Drug: BI 10773Drug: Ramipril

Interventions

BI 10773DRUG

medium dose, oral administration

BI 10773 + Ramipril
RamiprilDRUG

Medium dose oral administration on day 2-5

BI 10773 + Ramipril

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. healthy male and female subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1245.45.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Related Publications (1)

  • Macha S, Sennewald R, Rose P, Schoene K, Pinnetti S, Woerle HJ, Broedl UC. Lack of clinically relevant drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and verapamil, ramipril, or digoxin in healthy volunteers. Clin Ther. 2013 Mar;35(3):226-35. doi: 10.1016/j.clinthera.2013.02.015.

    PMID: 23497760DERIVED

MeSH Terms

Interventions

empagliflozinRamipril

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

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

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
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

January 20, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Last Updated

July 22, 2014

Results First Posted

July 22, 2014

Record last verified: 2014-06

Locations

DE(1)