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

NCT ID: NCT02231931

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2015-01-01

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A (Reference 1) Digoxin

1 tablet as single dose, fasted

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

single dose, fasted

B (Reference 2) Furosemide

oral solution, as single dose, fasted

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

single dose, fasted

C (Reference 3) Metformin hydrochloride

1 film-coated tablet as single dose, fasted

Group Type EXPERIMENTAL

Metformin hydrochloride

Intervention Type DRUG

single dose, fasted

D (Reference 4) Rosuvastatin

1 film-coated tablet as single dose, fasted

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

single dose, fasted

E (Test) 1

Digoxin (1 tablet), Furosemide (0.5 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted

Group Type EXPERIMENTAL

Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin

Intervention Type DRUG

fasted

F (Test 2)

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

Group Type EXPERIMENTAL

Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin

Intervention Type DRUG

fasted

G (Test 3)

Digoxin (1 tablet), Furosemide (2.0 mL oral solution), Metformin hydrochloride (1 film-coated tablet), Rosuvastatin (1 film-coated tablet), fasted

Group Type EXPERIMENTAL

Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin

Intervention Type DRUG

fasted

Interventions

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Digoxin

single dose, fasted

Intervention Type DRUG

Rosuvastatin

single dose, fasted

Intervention Type DRUG

Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin

fasted

Intervention Type DRUG

Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin

fasted

Intervention Type DRUG

Metformin hydrochloride

single dose, fasted

Intervention Type DRUG

Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin

fasted

Intervention Type DRUG

Furosemide

single dose, fasted

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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352.2082.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2014-001940-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

352.2082

Identifier Type: -

Identifier Source: org_study_id

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