tolerability and pharmacokinetics of a single 900 mg oral dose of bia 2-093 and oxcarbazepine in healthy volunteers

Conditions: Epilepsy

Summary: to investigate the pharmacokinetics of a single 900 mg oral dose of bia 2-093 and a single 900 mg oral dose of oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of bia 2-093 and oxcarbazepine.

single centre, open label, balanced randomised, two-way crossover study in 12 healthy volunteers. the study consisted of 2 periods separated by a washout period of 7 days or more. on each of the study periods the volunteers received either a single 900 mg oral dose of bia 2-093 or a single 900 mg oral dose of oxcarbazepine.

Eligibility criteria:
inclusion criteria: * male or 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, neurological examination, and 12-lead ecg. * subjects who had clinical laboratory tests acceptable. * subjects who were negative for hbs ag, anti-hcv ab and hiv-1 and hiv-2 ab tests at screening. * subjects who were negative for alcohol and 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. * in case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier, intrauterine device or abstinence. * in case of female volunteers, subjects who had a negative pregnancy test at screening and admission 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 21 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 prescription drugs within 4 weeks of first dosing. * subjects who had used 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 2 months of their first admission. * 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. * in case of female volunteers, subjects who were pregnant or breast-feeding. * in case of female volunteers, subjects who were of childbearing potential and did not use an approved effective contraceptive method or used oral contraceptives.

Keywords: eslicarbazepine acetate epilepsy oxcarbazepine