Comparative study on the bioavailability (rate and extent of absorption) between soft capsules of 100 mg of ciclosporine from two different pharmaceutical laboratories.
- Conditions
- 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).Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2013-001542-34-PT
- Lead Sponsor
- AIBILI - Associação para Investigação Biomédica e Inovação em Luz e Imagem
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Adverse events.;Timepoint(s) of evaluation of this end point: Throughout the study.