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Trial record 40 of 187 for:    BI10773

Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02172222
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 10773 Drug: Linagliptin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Multiple Doses BI 10773 50 mg and Linagliptin 5 mg After Concomitant Administration Compared to Multiple Doses of BI 10773 50 mg and Linagliptin 5mg Administered Alone to Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
Study Start Date : July 2009
Actual Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence ABC
  1. Treatment A: BI 10773 once daily from day 1 to 5
  2. Treatment B: BI10773 and linagliptin once daily from day 1 to 7
  3. Treatment C: Linagliptin once daily from day 1 to 7
Drug: BI 10773
Drug: Linagliptin
Experimental: Sequence CAB
  1. Treatment C: Linagliptin once daily from day 1 to 7
  2. Treatment A: BI 10773 once daily from day 1 to 5
  3. Treatment B: BI10773 and linagliptin once daily from day 1 to 7
Drug: BI 10773
Drug: Linagliptin



Primary Outcome Measures :
  1. AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to day 8 ]
  2. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to day 8 ]

Secondary Outcome Measures :
  1. tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state) [ Time Frame: up to day 8 ]
  2. Urine glucose excretion (UGE) [ Time Frame: Pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 hours after the last dosing of each visit ]
  3. Plasma DPP-4 (Dipeptidyl-peptidase 4) inhibition [ Time Frame: 2 hours and 24 hours after last administration of study drug ]
  4. Changes from baseline in physical examination [ Time Frame: Baseline and within 5 days after last study drug administration ]
  5. Changes from baseline in vital signs (blood pressure, pulse rate) [ Time Frame: Baseline, day 1 and within 5 days after last study drug administration ]
  6. Changes from baseline in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline and within 5 days after last study drug administration ]
  7. Changes from baseline clinical laboratory tests [ Time Frame: Baseline, day 1 and within 5 days after last study drug administration ]
  8. Incidence of adverse events [ Time Frame: Up to 56 days ]
  9. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Within 5 days after last study drug administration ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers according to the following criteria:

    • Based upon a complete medical history and physical examination including vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram) and clinical laboratory tests
  • Age 18 to 50 years (inclusive)
  • BMI 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

Exclusion Criteria:

  • Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 30 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172222     History of Changes
Other Study ID Numbers: 1245.30
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Empagliflozin
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