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

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA 3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4 different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of standard levodopa 100 mg/benserazide 25 mg (Madopar® 125) in adult male and female healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Benserazide; Benserazide, levodopa drug combination; Levodopa

Criteria

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.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria, OR

• 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.