Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics

Inclusion Criteria

• •Male or female subjects aged between 18 and 45 years, inclusive.
• •Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
• •Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
• •Subjects who had clinical laboratory tests clinically acceptable at screening and admission.
• •Subjects who had negative tests for HBsAg, anti-HCVAb and anti-HIV-1 and anti-HIV-2 Ab at screening.
• •Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission.
• •Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
• •Subjects who were able and willing to give written informed consent.
• •(If female) She was sterile or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
• •(If female) She had a negative urine pregnancy test at screening and admission.
• •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.
• •Subjects who had a clinically relevant surgical history.
• •Subjects who had a clinically relevant family history.
• •Subjects who had a history of relevant atopy.
• •Subjects who had a history of relevant drug hypersensitivity.
• •Subjects who had a history of alcoholism or drug abuse.
• •Subjects who consumed more than 21 units of alcohol a week.
• •Subjects who had a significant infection or known inflammatory process on screening or admission.
• •Subjects who had acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
• •Subjects who had used prescription or over-the-counter medication within 2 weeks of admission.
• •Subjects who had used any investigational drug or participated in any clinical trial within 3 months prior to screening.
• •Subjects who had donated or received any blood or blood products within 3 months prior to screening.
• •Subjects who were vegetarians, vegans or have medical dietary restrictions.
• •Subjects who cannot communicate reliably with the investigator.
• •Subjects who were unlikely to co-operate with the requirements of the study.
• •(If female) She was pregnant or breast-feeding.
• •(If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.