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:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01284621
First received: January 20, 2011
Last updated: October 4, 2012
Last verified: October 2012
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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 Pharmaceuticals:
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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| 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 June 18, 2013