single-dose and steady-state pharmacokinetics of bia 2-093 and its metabolites

Conditions: Epilepsy

Summary: the purpose of this study is to determine the effects of age on the pharmacokinetic profile of bia 2-093 and its active metabolites.

this was a single-centre, open-label, parallel group, non-randomised study with a single-dose phase (phase a) followed by a multiple-dose phase (phase b), in 12 healthy elderly and 12 healthy young subjects. during the whole study, subjects were to receive a single 600 mg dose of bia 2-093 (phase a) followed by 600 mg bia 2-093 once daily for 8 days in phase b. phase b was to begun 96 hours post-phase a dose.

Eligibility criteria:
inclusion criteria: * male or female subjects aged between 18 and 40 years, inclusive or male or female subjects aged 65 years or more. * if young, subjects who were within 15% of ideal body weight or, if elderly, subjects who were within 20% of ideal body weight according to the metropolitan life insurance table. * subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ecg. * subjects who had clinical laboratory tests acceptable to the investigator. * subjects who were negative for hbsag, hcvab and hiv-1 and hiv-2 ab tests at screening. * subjects who were negative for alcohol and drugs of abuse at screening. * 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 female) she was not of childbearing potential by reason of surgery or menopause or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine. * (if female and with less than 40 years old) she had a negative pregnancy test at screening. exclusion criteria: * subjects who did not conform to the above inclusion criteria. * 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 14 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 used drugs within 2 weeks 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 this study. * subjects who had previously received bia 2-093. * subjects who had donated and/or received any blood or blood products within the previous 2 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. * 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 authorised effective contraceptive method.

Keywords: eslicarbazepine acetate bia 2-093