Pharmacokinetic of Levodopa Study in Healthy Males

Exclusion Criteria

• •Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease or cancer (except local non-melanoma skin cancer) within the previous 2 years.
• •Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol for occasional pain is allowed.
• •Any clinically significant abnormal laboratory value or ECG (such as prolonged QTcF \> 450 ms or QRS \> 120 ms) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he takes part in the study.
• •Known hypersensitivity to the active substances or the excipients of the drugs.
• •History of vasovagal collapses or vagal reactions with unexplained reason within the previous 2 years or a tendency for vasovagal reactions during blood sampling.
• •HR \< 40 beats per minute (bpm) or \> 90 bpm in the supine position after 5 min rest at the screening visit.
• •At the screening visit:systolic BP \< 90 mmHg or \> 150 mmHg in the supine position after 5 min rest and diastolic BP \< 50 mmHg or \> 90 mmHg in the supine position after 5 min rest.
• •History of anaphylactic/anaphylactoid reactions.
• •Strong tendency to motion sickness.
• •Recent or current (suspected) drug abuse.
• •Recent or current alcohol abuse; regular drinking of more than 21 units per week (1 unit = 4 cl spirits or equivalent).
• •Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study (from the screening visit to the end-of-study visit).
• •Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from using caffeine containing beverages 10 h before and during the study periods.
• •Blood donation or loss of a significant amount of blood within 90 days before the first study treatment administration.
• •Participation in an investigational drug study or administration of an investigational drug within 90 days before the first study treatment administration.
• •Unsuitable veins for repeated venipuncture or cannulation.
• •Predictable poor compliance or inability to communicate well with the study centre personnel.
• •Inability to participate in all treatment periods.