Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)

Inclusion Criteria

• •Male and female subjects aged between 18 and 45 years, inclusive.
• •Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
• •Subjects who were healthy as determined by pre study medical history, physical examination, and 12- lead ECG.
• •Subjects who had clinical laboratory tests acceptable to the investigator.
• •Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
• •Subjects who were negative for 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 a woman) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
• •Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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 28 units of alcohol a week.
• •Subjects who had a significant infection or known inflammatory process on screening and/or admission.
• •Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
• •Subjects who had an acute infection such as influenza at the time of screening and/or admission.
• •Subjects who had used prescription drugs within 4 weeks of first dosing.
• •Subjects who had used oral contraceptives or over the counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
• •Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to the study.
• •Subjects who had previously received BIA 3-202.
• •Subjects who had donated and/or received any blood or blood products within the previous 3 months prior to screening.
• •Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
• •Subjects who could not communicate reliably with the investigator.
• •Subjects who were unlikely to co-operate with the requirements of the study.
• •(If woman) She was pregnant or breast-feeding.
• •(If woman) She was at childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.
• •Subjects who were unwilling or unable to give written informed consent.