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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

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Empagliflozin (fixed dose combination) Drug: Linagliptin (fixed dose combination) Drug: Metformin HCl (fixed dose combination) Drug: Empagliflozin Drug: Linagliptin Drug: Metformin HCl Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test treatment (T)
Low strength empagliflozin/linagliptin/metformin XR fixed dose combination tablet
Drug: Empagliflozin (fixed dose combination)
single dose

Drug: Linagliptin (fixed dose combination)
single dose

Drug: Metformin HCl (fixed dose combination)
single dose

Experimental: Reference treatment (R)
Single tablets of empagliflozin + linagliptin + metformin XR
Drug: Empagliflozin
single dose

Drug: Linagliptin
single dose

Drug: Metformin HCl
single dose




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Cmax (maximum measured concentration of the analyte in plasma) for empagliflozin, linagliptin, and metformin [ Time Frame: Up to 72 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Number [N (%)] of subjects with drug-related adverse events [ Time Frame: Up to 14 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629054


Locations
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Germany
Humanpharmakologisches Zentrum Biberach
Biberach, Germany, 88397
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03629054     History of Changes
Other Study ID Numbers: 1361-0011
2018-001266-42 ( EudraCT Number )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
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'.

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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

Additional relevant MeSH terms:
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Metformin
Empagliflozin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors