Status:
COMPLETED
Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Parkinson
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a w...
Eligibility Criteria
Inclusion
- A signed and dated informed consent form before any study-specific screening procedure was performed;
- Male or female subjects aged 18 to 45 years, inclusive;
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive;
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
- Negative tests for hepatitis B surface antigen (HBsAg), anti- hepatitis C virus antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) at screening;
- Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
- Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
- Non-smokers or ex-smokers for at least 3 months;
- Able to participate, and willing to give written informed consent and comply with the study restrictions.
- If female:
- She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used an effective non-hormonal method of contraception \[intrauterine device or intrauterine system; condom or occlusive cap (diaphragm or cervical or vault caps) with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject\] for all the duration of the study;
- She had a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to each treatment period.
Exclusion
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or had a clinically relevant surgical history;
- Had clinically relevant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the liver function tests;
- Had a history of relevant atopy or drug hypersensitivity;
- Had a history of alcoholism and/or drug abuse;
- Consumed more than 14 units of alcohol per week \[1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)\];
- Had a significant infection or known inflammatory process on screening or admission to each treatment period;
- Had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
- Had used medicines within 2 weeks of admission to first period that could affect the safety or other study assessments, in the Investigator's opinion;
- Had previously received opicapone;
- Had used any investigational drug or participated in any clinical trial within 90 days prior to screening;
- Had participated in more than 2 clinical trials within the 12 months prior to screening;
- Had donated or received any blood or blood products within the 3 months prior to screening;
- Were vegetarians, vegans or had medical dietary restrictions;
- Could not communicate reliably with the Investigator;
- Were unlikely to co-operate with the requirements of the study;
- Were unwilling or unable to give written informed consent;
- If female:
- She was pregnant or breast-feeding.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT02305277
Start Date
March 1 2014
End Date
June 1 2014
Last Update
March 12 2025
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