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This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills

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ClinicalTrials.gov Identifier: NCT03629054
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 9, 2018
First Posted Date  ICMJE August 14, 2018
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE August 27, 2018
Actual Primary Completion Date November 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • 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) for empagliflozin and metformin [ Time Frame: Up to 72 hours ]
  • AUC0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 h) for linagliptin [ Time Frame: Up to 72 hours ]
  • Cmax (maximum measured concentration of the analyte in plasma) for empagliflozin, linagliptin, and metformin [ Time Frame: Up to 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03629054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • AUC0-∞ (area under the concentration-time curve of the analyte (empagliflozin) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 72 hours ]
  • AUC0-∞ (area under the concentration-time curve of the analyte (linagliptin) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 72 hours ]
  • AUC0-∞ (area under the concentration-time curve of the analyte (metformin) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 72 hours ]
  • Number [N (%)] of subjects with drug-related adverse events [ Time Frame: Up to 14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • AUC0-∞ (area under the concentration-time curve of the analyte (empagliflozin) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 72 hours ]
  • AUC0-∞ (area under the concentration-time curve of the analyte (linagliptin) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 72 hours ]
  • AUC0-∞ (area under the concentration-time curve of the analyte (metformin) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
Official Title  ICMJE Bioequivalence of a Low Strength Fixed Dose Combination Tablet of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin, and Metformin Extended Release Tablets Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)
Brief Summary

The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual components given in separate tablets (Reference, R) when administered together after a high-fat, high-calorie meal.

The assessment of safety and tolerability will be the secondary objective of this trial.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Empagliflozin (fixed dose combination)
    single dose
  • Drug: Linagliptin (fixed dose combination)
    single dose
  • Drug: Metformin HCl (fixed dose combination)
    single dose
  • Drug: Empagliflozin
    single dose
  • Drug: Linagliptin
    single dose
  • Drug: Metformin HCl
    single dose
Study Arms  ICMJE
  • Experimental: Test treatment (T)
    Low strength empagliflozin/linagliptin/metformin XR fixed dose combination tablet
    Interventions:
    • Drug: Empagliflozin (fixed dose combination)
    • Drug: Linagliptin (fixed dose combination)
    • Drug: Metformin HCl (fixed dose combination)
  • Experimental: Reference treatment (R)
    Single tablets of empagliflozin + linagliptin + metformin XR
    Interventions:
    • Drug: Empagliflozin
    • Drug: Linagliptin
    • Drug: Metformin HCl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 5, 2018
Actual Primary Completion Date November 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 55 years (incl.)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
  • Female subjects of childbearing potential willing to use adequate contraception.
  • Further inclusion criteria apply

Exclusion criteria:

  • Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • Further exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03629054
Other Study ID Numbers  ICMJE 1361-0011
2018-001266-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP