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Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02221414
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to demonstrate bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 500 mg administered together

Condition or disease Intervention/treatment Phase
Healthy Drug: Linagliptin/Metformin FDC Drug: Linagliptin Drug: Metformin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover, Phase I Trial)
Study Start Date : January 2010
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A (FDC) Drug: Linagliptin/Metformin FDC
Active Comparator: Treatment B (single agents) Drug: Linagliptin
Drug: Metformin



Primary Outcome Measures :
  1. AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h) [ Time Frame: up to 72 hours ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]
  3. AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours ]

Secondary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours ]
  2. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 72 hours ]
  3. %AUCtz-∞ (percentage of AUCtz-∞ obtained by extrapolation) [ Time Frame: up to 72 hours ]
  4. AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) [ Time Frame: up to 72 hours ]
  5. tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]
  6. λz (terminal elimination rate constant in plasma) [ Time Frame: up to 72 hours ]
  7. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours ]
  8. MRTpo (mean residence time of the analyte in the body after peroral administration) [ Time Frame: up to 72 hours ]
  9. CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: up to 72 hours ]
  10. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 72 hours ]
  11. Number of subjects with clinically significant findings in vital signs [ Time Frame: up to 7 days after drug administration ]
    blood pressure, pulse rate

  12. Number of subjects with clinically significant findings in 12-lead electrocardiogram (ECG) [ Time Frame: up to 7 days after drug administration ]
  13. Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 7 days after drug administration ]
  14. Number of subjects with adverse events [ Time Frame: up to 7 days after drug administration ]
  15. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 7 days after drug administration ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy men and women according to the following criteria: based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
  2. Age 21 to 50 years (inclusive)
  3. Body mass index (BMI) 18.5 to 29.9 kg/m2 (inclusive)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts
  7. Chronic or relevant acute infections
  8. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
  9. Intake of drugs within 1 month or less than 10 half-lives of the respective drug prior to first study drug administration
  10. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
  11. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
  12. Alcohol abuse (average consumption of more than 20 g/day in women and 30 g/day in men)
  13. Drug abuse
  14. Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)
  15. Any laboratory value outside the reference range of clinical relevance
  16. Inability to comply with dietary regimen of trial site

    For female subjects of childbearing potential only:

  17. Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
  18. No adequate contraception during the study and until 1 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal intrauterine device, or surgical sterilization (including hysterectomy).
  19. Lactation

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02221414     History of Changes
Other Study ID Numbers: 1288.2
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

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