Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
Overview[ - collapse ][ - ]
Purpose | The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high fat, high caloric meal. The assessment of safety and tolerability will be an additional objective of this trial. |
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Condition | Healthy |
Intervention | Drug: empagliflozin Drug: metformin (Glucophage®) Drug: metformin (Glucophage®) Drug: empagliflozin Drug: empagliflozin and metformin Drug: empagliflozin and metformin |
Phase | Phase 1 |
Sponsor | Boehringer Ingelheim |
Responsible Party | Boehringer Ingelheim |
ClinicalTrials.gov Identifier | NCT01844531 |
First Received | April 29, 2013 |
Last Updated | December 11, 2013 |
Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | April 29, 2013 |
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Last Updated Date | December 11, 2013 |
Start Date | April 2013 |
Estimated Primary Completion Date | November 2013 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [Time Frame: up to 72 hours after drug intake] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets |
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Official Title | Bioequivalence of Empagliflozin/Metformin (500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-way Crossover Study) |
Brief Summary | The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet [Reference 1] and low dose empagliflozin tablet + Glucophage® 500 mg tablet [Reference 2]) when administered together after a high fat, high caloric meal. The assessment of safety and tolerability will be an additional objective of this trial. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Healthy |
Intervention | Drug: empagliflozin single tablet empagliflozin Drug: metformin (Glucophage®) single tablet metformin Drug: metformin (Glucophage®) single tablet metformin Drug: empagliflozin single tablet empagliflozin Drug: empagliflozin and metformin FDC tablet empagliflozin and metformin Drug: empagliflozin and metformin FDC tablet empagliflozin and metformin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 24 |
Estimated Completion Date | November 2013 |
Estimated Primary Completion Date | November 2013 |
Eligibility Criteria | Inclusion criteria: 1. Healthy male and female subjects 2. Subjects must be able to understand and comply with study requirements 3. Age 18 to 50 years 4. Body mass index (BMI) 18.5 to 29.9 kg/m2 Exclusion criteria: 1. Any relevant deviation from healthy conditions |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Germany |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01844531 |
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Other Study ID Numbers | 1276.6 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Boehringer Ingelheim |
Study Sponsor | Boehringer Ingelheim |
Collaborators | Not Provided |
Investigators | Study Chair: Boehringer Ingelheim Boehringer Ingelheim |
Verification Date | December 2013 |
Locations[ + expand ][ + ]
1276.6.1 Boehringer Ingelheim Investigational Site | Biberach, Germany |
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