Healthy volunteers (indication: diuretic. The trial intends to assess if the reference product and a generic product are bioequivalents).
Conditions
Interventions
Trade Name: Lasix
Product Name: Lasix
Pharmaceutical Form: Tablet
Trade Name: Furosemida Ratiopharm 40 mg Comprimidos
Product Name: Furosemida Ratiopharm 40 mg Comprimidos
Pharmaceutical Form: Tablet
Sponsors
AIBILI - Associação para Investigação Biomédica e Inovação em Luz e Imagem
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female aged 18 yeras or older; Body mass index between 18.5 and 30 Kg/m2; No clinically significant abnormalities assessed through clinical history, physical examination, blood laboratory analyses and ECG; Willingness to participate in each visit/administration; Signed Informed Consent Form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Tobacco use; Allergy or hypersensitivity to furosemide; Creatinine serum = 1.5 mg/dl; Benign prostatic hypertrophy or known urethral narrowing; Hyponatraemia; Hypokalaemia; Hepatic illness (assessed by the clinical examination and blood analyses, a mild increase of indirect bilirubin during fasting is acceptable); Positive results for HIV-1, HIV-2, Hepatitis B and Hepatitis C tests (anti-HIV-1 Ab, anti-HIV-2 Ab, HbsAg and anti-HCV Ab); Pregnancy, breast-feeding or inadequate contraception in women likely to become pregnant; Important cardiovascular complications: cardiac failure, history of myocardial infarction, angina or recent vascular accident; Gastro-duodenal peptic ulcer; Haemorrhagic diatheses; Chronic alcohol intake (> 80 g/day ethanol); Toxicomanias (consumption of drugs of abuse) and individuals known to be at high risk for AIDS; Diabets mellitus non-treated or treated with insulin or oral antidiabetics; Patients with gout or hyperuricemia; Organic neurological illnesses; Chronic medication intake (including herbal remedies), except contraception medication (which must be used during Visits D1 and D2); vegetarians, vegans or have medical dietary restrictions; have used any investigational drug or participated in any clinical trial within three months; have donated or received any blood or blood products within the previous two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Bioequivalence.;Secondary Objective: Safety.;Primary end point(s): Pharmacokinetic parameters of both IMP.;Timepoint(s) of evaluation of this end point: Calculation of pharmacokinetic parameters after administration of each IMP, based on blood sampling at pre-dose, 0.25; 0.5; 0.75; 1; 1.25; 1.5; 1.75; 2; 2.5; 3; 4; 5; 6; 7; 8; 10 and 12 hours after admininstration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events.;Timepoint(s) of evaluation of this end point: Throughout the study. | — |
Countries
Portugal
Contacts
Public ContactPrincipal Investigator
AIBILI - Associação para Investigação Biomédica e Inovação em Luz e Imagem
Outcome results
None listed