Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of three single oral doses of nebicapone (50 mg, 100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled release levodopa 100 mg/benserazide 25 mg (Madopar® HBS 125).

• 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:

Subjects were eligible for entry into the study if they fulfilled the following 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 test results clinically acceptable at screening and admission to first treatment period.

• Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.

• Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.

• Subjects who were non-smokers or who smoked ≤ 10 cigarettes or equivalent per day.

• Subjects who were able and willing to give written informed consent.

• (If female) 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.

• (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

Subjects were not eligible for entry into the study if they fulfilled the following 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, 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 glaucoma.

• 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 first admission.

• Subjects who had acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).

• Subjects who had used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.

• Subjects who had used any investigational drug or participated in any clinical trial within 2 months of their first admission.

• Subjects who had donated or received any blood or blood products within the previous 2 months prior to screening.

• Subjects who were vegetarians, vegans or have 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.

• Subjects who were unwilling or unable to give written informed consent.

• (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 (double-barrier, intra-uterine device or abstinence) or she used oral contraceptives.