Status:
COMPLETED
Magnetic Marker Monitoring of Furosemide-containing Gastroretentive Formulation in Healthy Male Subjects (Fasting and Fed Conditions)
Lead Sponsor:
LTS Lohmann Therapie-Systeme AG
Conditions:
Gastroretentive Drug Formulation of Furosemide
Oedema
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Furosemide is a diuretic drug, used in the treatment of oedematous states associated with cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to thiazide diuretics. Fur...
Detailed Description
Furosemide is a diuretic drug, widely used in the treatment of oedematous states associated with cardiac, renal, and hepatic disorder, and may be effective in patients unresponsive to thiazide diureti...
Eligibility Criteria
Inclusion
- sex: male
- ethnic origin: Caucasian
- age: 18 years to 55 years
- body-mass index (BMI): \> or = 19 kg/m² and \< or = 27 kg/m²
- good state of health
- non-smoker or ex-smoker for at least 1 month
- written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
Exclusion
- existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing gastrointestinal diseases or pathological findings, which might interfere with the safety and tolerability or with gastric emptying and the gastrointestinal transport (e.g. inflammatory bowel diseases, ileus)
- history of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- any surgery at the gastrointestinal tract, which might interfere with the safety of the test product or any stomach reduction like Bioenterics Intragastric Balloon (BIB) or gastric banding
- known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
- known allergic reactions to sulphonamide
- subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- heart rate \< 50 bpm or \> 90 bpm
- systolic blood pressure of \< 100 mmHg and \> 140 mmHg, diastolic blood pressure of \< 60 mmHg and \>90 mmHg
- laboratory values, especially for sodium, potassium, calcium, creatinine, urea, uric acid, and blood glucose out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
- positive anti-human immunodeficiency virus-test (if positive to be verified by western blot), surface antigen of the hepatitis B virus (HBs-AG)test \[if positive to be verified by test for hepatitis B Core (HBc-IgM)\] or anti-hepatitis C virus-test
- renal failure with anuria
- coma and praecoma hepatica
- severe hypokalemia and/or hyponatremia
- hypovolemia or dehydration
- subjects with manifest or latent diabetes mellitus or gout
- subjects with cerebrovascular insufficiency or coronary heart disease
- subjects with bladder outlet obstruction (BOO) e.g. prostatic hypertrophy, hydronephrosis or ureteral stenosis
- hypoproteinemia
- liver cirrhosis and simultaneous limitation of kidney function
- acute or chronic diseases which could affect gastric emptying and the gastrointestinal transport
- history of or current drug or alcohol dependence
- positive alcohol or drug test at screening examination
- regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day
- subjects who are on a diet which could affect gastric emptying and the gastro-intestinal transport
- regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
- subjects with claustrophobia
- ferromagnetic implants or any other magnetic disturbance, which can affect the Magnetic Marker Monitoring measurement
- blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject
- participation in a clinical trial during the last two months prior to individual enrolment of the subject
- regular treatment with any systemically available medication including all ototoxic medication like aminoglycosides and medication which could affect gastric emptying and the gastrointestinal transport (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists) or antibiotics
- subjects, who report a frequent occurrence of migraine attacks
- subjects suspected or known not to follow instructions
- subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
- subjects who have forfeited their own freedom by administrative or legal award, or who are under guardianship or have been admitted in a sanitary or social institution
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01887379
Start Date
June 1 2013
End Date
August 1 2013
Last Update
December 12 2013
Active Locations (1)
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1
SocraTec R&D GmbH Clinical Pharmacology Unit
Berlin, Germany, 10578