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Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02220647
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 19, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date August 20, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • 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 ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2014)
  • 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 ]
  • 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 ]
  • %AUCtz-∞ (percentage of AUCtz-∞ obtained by extrapolation) [ Time Frame: up to 72 hours ]
  • 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 ]
  • tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 72 hours ]
  • λz (terminal elimination rate constant in plasma) [ Time Frame: up to 72 hours ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours ]
  • MRTpo (mean residence time of the analyte in the body after peroral administration) [ Time Frame: up to 72 hours ]
  • CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: up to 72 hours ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 72 hours ]
  • Number of subjects with clinically significant findings in vital signs [ Time Frame: up to 7 days after drug administration ]
    blood pressure, pulse rate
  • Number of subjects with clinically significant findings in 12-lead electrocardiogram (ECG) [ Time Frame: up to 7 days after drug administration ]
  • Number of subjects with clinically significant findings in laboratory tests [ Time Frame: up to 7 days after drug administration ]
  • Number of subjects with adverse events [ Time Frame: up to 7 days after drug administration ]
  • Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 7 days after drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers
Official Title  ICMJE Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets Administered Together in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover, Phase I Trial)
Brief Summary Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850 mg administered together
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: Linagliptin/Metformin FDC
  • Drug: Linagliptin
  • Drug: Metformin
Study Arms  ICMJE
  • Experimental: Treatment A (FDC)
    Intervention: Drug: Linagliptin/Metformin FDC
  • Active Comparator: Treatment B (single agents)
    Interventions:
    • Drug: Linagliptin
    • Drug: Metformin
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 19, 2014)
96
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) 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, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220647
Other Study ID Numbers  ICMJE 1288.3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2014

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