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Trial record 69 of 3092 for:    Area Under Curve AND Healthy

DDI (Effect of Metformin and Furosemide on Rosuvastatin PK)

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ClinicalTrials.gov Identifier: NCT02574845
Recruitment Status : Completed
First Posted : October 14, 2015
Results First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this trial is to investigate the relative bioavailability of rosuvastatin when given alone (Reference treatment, R) compared to when given together with one of the three different doses of metformin (10 mg, Test treatment 1 (T1); 50 mg (T2); 500 mg (T3)) or one of the two doses of furosemide (1 mg (T4); 5 mg (T5)).

Condition or disease Intervention/treatment Phase
Healthy Drug: Rosuvastatin Drug: Metformin HCl Drug: Furosemide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Different Doses of Metformin or Furosemide on Rosuvastatin Pharmacokinetics Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Six-way Crossover Study)
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: R (Reference) Rosuvastatin
1film-coated tablet as single dose, fasted
Drug: Rosuvastatin
Experimental: T1 (Test 1) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (10 mg) as single dose, fasted
Drug: Rosuvastatin
Drug: Metformin HCl
Experimental: T2 (Test 2) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (50 mg) as single dose, fasted
Drug: Rosuvastatin
Drug: Metformin HCl
Experimental: T3 (Test 3) Rosuvastatin + Metformin HCl
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (500 mg) as single dose, fasted
Drug: Rosuvastatin
Drug: Metformin HCl
Experimental: T4 (Test 4) Rosuvastatin + Furosemide
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (1 mg) as single dose, fasted
Drug: Rosuvastatin
Drug: Furosemide
Experimental: T5 (Test 5) Rosuvastatin + Furosemide
Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (5 mg) as single dose, fasted
Drug: Rosuvastatin
Drug: Furosemide



Primary Outcome Measures :
  1. Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter. ]
    This outcome measure presents the area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

  2. Maximum Concentration of Rosuvastatin (Cmax) [ Time Frame: Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter. ]
    This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax).


Secondary Outcome Measures :
  1. Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞) [ Time Frame: Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter. ]
    This outcome measure presents area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
  2. Age of 18 to 55 years (incl.)
  3. BMI 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 GCP and local legislation

Exclusion criteria:

  1. Any finding in the medical examination (including BP, PR or ECG) 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 45 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. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics 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
  8. History of relevant orthostatic hypotension, fainting spells, or blackouts
  9. Chronic or relevant acute infections
  10. History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
  11. Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
  12. Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
  13. Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
  14. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  15. Inability to refrain from smoking on specified trial days
  16. Alcohol abuse (consumption of more than 30 g per day)
  17. Drug abuse or positive drug screening
  18. Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
  19. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
  20. Inability to comply with dietary regimen of trial site
  21. Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study

    In addition, the following trial-specific exclusion criteria apply:

  22. Myopathy
  23. Hereditary galactose or fructose intolerance, lactase deficiency, or glucose-galactose malabsorption
  24. Allergy or hypersensitivity against sulfonamides

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): NCT02574845


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02574845     History of Changes
Other Study ID Numbers: 352.2094
2015-003052-46 ( EudraCT Number: EudraCT )
First Posted: October 14, 2015    Key Record Dates
Results First Posted: February 13, 2017
Last Update Posted: February 13, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
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Metformin
Rosuvastatin Calcium
Furosemide
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