Overview

This trial is active, not recruiting.

Condition healthy
Treatments digoxin, rosuvastatin, digoxin, furosemide, metformin hydrochloride, rosuvastatin, metformin hydrochloride, furosemide
Phase phase 1
Sponsor Boehringer Ingelheim
Start date September 2014
End date January 2015
Trial size 24 participants
Trial identifier NCT02231931, 2014-001940-40, 352.2082

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1 tablet as single dose, fasted
digoxin
single dose, fasted
(Experimental)
oral solution, as single dose, fasted
furosemide
single dose, fasted
(Experimental)
1 film-coated tablet as single dose, fasted
metformin hydrochloride
single dose, fasted
(Experimental)
1 film-coated tablet as single dose, fasted
rosuvastatin
single dose, fasted
(Experimental)
Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted
digoxin, furosemide, metformin hydrochloride, rosuvastatin
fasted
(Experimental)
Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (2 film-coated tablets), Rosuvastatin (1 film-coated tablet), fasted
digoxin, furosemide, metformin hydrochloride, rosuvastatin
fasted
(Experimental)
Digoxin (1 tablet), Furosemide (2.0 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted
digoxin, furosemide, metformin hydrochloride, rosuvastatin
fasted

Primary Outcomes

Measure
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
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
Furosemide: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 36 hours
Digoxin, Metformin, Rosuvastatin: Cmax (maximum measured concentration of the analyte in plasma)
time frame: up to 96 hours

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male participants from 18 years up to 50 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.