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CompletedNCT02221401Updated Aug 20, 2014

Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers

A Phase 1 interventional study of Linagliptin/Metformin FDC and Linagliptin in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-20.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 ECG, clinical laboratory tests
  2. Age 18 to 55 years (inclusive)
  3. Body mass index (BMI) of 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 local legislation

Exclusion criteria

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, sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilization (including hysterectomy). Women who did not have a vasectomised partner, were not sexually abstinent or surgically sterile were asked to use an additional barrier method (e.g. condom).
  19. Lactation
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Treatment A (FDC)

    Drug: Linagliptin/Metformin FDC

  • Active comparator
    Treatment B (single agents)

    Drug: Linagliptin · Drug: Metformin

Interventions

  • DrugLinagliptin/Metformin FDC
  • DrugLinagliptin
  • DrugMetformin
06

What researchers measure

Primary outcomes

  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 outcomes

  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 until 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

    blood pressure, pulse rate

    Time frame: up to 7 days after last drug administration

  12. Number of subjects with clinically significant findings in 12-lead electrocardiogram (ECG)

    Time frame: up to 7 days after last drug administration

  13. Number of subjects with clinically significant findings in laboratory tests

    Time frame: up to 7 days after last drug administration

  14. Number of subjects with adverse events

    Time frame: up to 7 days after last drug administration

  15. Assessment of tolerability by investigator on a 4-point scale

    Time frame: up to 7 days after last drug administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02221401
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Aug 20, 2014
Start date
Jan 2010
Primary completion
Apr 2010
Last update
Aug 20, 2014
View the source record on ClinicalTrials.gov ↗

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