Overview

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 (MadoparĀ® 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.