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Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin

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ClinicalTrials.gov Identifier: NCT02231931
Recruitment Status : Completed
First Posted : September 4, 2014
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the mutual interaction potential of digoxin, furosemide, metformin, and rosuvastatin when given alone or together as a cocktail, and to investigate the effect of high doses of metformin or furosemide on pharmacokinetics of the other cocktail compounds

Condition or disease Intervention/treatment Phase
Healthy Drug: Digoxin Drug: Rosuvastatin Drug: Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin Drug: Metformin hydrochloride Drug: Furosemide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of a Single Oral Dose of Digoxin, Furosemide, Metformin, and Rosuvastatin Given Alone and All Together as a Cocktail, and Investigation of the Effect of Increased Doses of Metformin or Furosemide on Relative Bioavailability of the Other Cocktail Compounds in Healthy Male Subjects
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A (Reference 1) Digoxin
1 tablet as single dose, fasted
Drug: Digoxin
single dose, fasted

Experimental: B (Reference 2) Furosemide
oral solution, as single dose, fasted
Drug: Furosemide
single dose, fasted

Experimental: C (Reference 3) Metformin hydrochloride
1 film-coated tablet as single dose, fasted
Drug: Metformin hydrochloride
single dose, fasted

Experimental: D (Reference 4) Rosuvastatin
1 film-coated tablet as single dose, fasted
Drug: Rosuvastatin
single dose, fasted

Experimental: E (Test) 1
Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted
Drug: Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin
fasted

Experimental: F (Test 2)
Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (2 film-coated tablets), Rosuvastatin (1 film-coated tablet), fasted
Drug: Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin
fasted

Experimental: G (Test 3)
Digoxin (1 tablet), Furosemide (2.0 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted
Drug: Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin
fasted




Primary Outcome Measures :
  1. Digoxin, Metformin, Rosuvastatin: 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) [ Time Frame: up to 96 hours ]
  2. Furosemide: 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) [ Time Frame: up to 36 hours ]
  3. Furosemide: Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 36 hours ]
  4. Digoxin, Metformin, Rosuvastatin: Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 96 hours ]

Secondary Outcome Measures :
  1. Furosemide: AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 36 hours ]
  2. Digoxin, Metformin, Rosuvastatin: AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 96 hours ]


Information from the National Library of Medicine

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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:

  1. Healthy male subjects according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, and clinical laboratory tests
  2. Age of 18 to 50 years (incl.)
  3. Body Mass Index of 18.5 to 29.9 kg/m2 (incl.)
  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:

  1. Any finding in the medical examination (including Blood Pressure, Pulse Rate, or Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
  2. 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 50 to 90 bpm
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
  7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

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): NCT02231931


Locations
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Germany
352.2082.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02231931    
Other Study ID Numbers: 352.2082
2014-001940-40 ( EudraCT Number: EudraCT )
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Metformin
Digoxin
Furosemide
Rosuvastatin Calcium
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Diuretics
Natriuretic Agents
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Anti-Arrhythmia Agents
Cardiotonic Agents
Protective Agents