Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01284621
First received: January 20, 2011
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: BI 10773
Drug: Ramipril
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Multiple Oral Doses of BI 10773 (25 mg) and Ramipril (5 mg) Administered Together Compared to Multiple Oral Doses of BI 10773 (25 mg) Alone and Ramipril (5 mg) Alone in Healthy Male and Female Volunteers (an Open Label, Randomised, Three Way Crossover, Clinical Phase I Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t of BI 10773, ramipril and ramiprilat [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t of BI 10773, ramipril and ramiprilat [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical examination, vital signs (blood pressure, pulse rate), electrocardiogramm, laboratory tests, adverse events and assessment of tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Pre-dose concentrations of the analyte in plasma prior to administration of the Nth dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Terminal rate constant in plasma at steady state [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Terminal half-life of the analyte in plasma at steady state [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mean residence time of the analyte in the body after oral administration at steady state [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Apparent clearance of the analyte in the plasma after extravascular administration at steady state [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Apparent volume of distribution at steady state during the terminal phase following an extravascular dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773
1 tablet per days for 5 days, oral administration with 240 mL water for each treatment
Drug: BI 10773
medium dose oral administration
Ramipril
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
Low dose oral administration on day 1
Drug: Ramipril
Medium dose oral administration on day 2-5
BI 10773 + Ramipril
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 10773
medium dose, oral administration
Drug: Ramipril
Medium dose oral administration on day 2-5
Drug: Ramipril
Low dose oral administration on day 1

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284621

Locations
Germany
1245.45.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01284621     History of Changes
Other Study ID Numbers: 1245.45, 2010-022717-25
Study First Received: January 20, 2011
Last Updated: October 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014