Healthy volunteers (indication: transplantation of solid organs and bone marrow and prevention of graft rejection after transplantation, treatment of transplant rejection in patients previously receiving other immunosupressive agents, endogenous uveitis, nephrotic syndrome, rhematoid arthritis, psoriasis, atopic dermatitis. The trial intends to assess if the reference product and a generic product are bioequivalent).
Conditions
Interventions
Trade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
Pharmaceutical Form: Capsule, soft
Trade Name: Ciclosporina Generis 100 mg Cápsulas moles
Product Name: Ciclosporina Generis 100 mg Cápsula
Sponsors
AIBILI - Associação para Investigação Biomédica e Inovação em Luz e Imagem
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male 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 cyclosporine; Serum creatinine within the normal laboratory range; 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); Important cardiovascular complications: cardiac failure, moderate to severe hypertension (systolic blood pressure above 140 mmHg, diastolic blood pressure above 90 mmHg), 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; Organic neurological illnesses; Chronic medication intake (including herbal remedies); 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: Calculatiion of pharmacokinetic parameters after admininstration of each IMP, based on blood sampling at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours after administration. | — |
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