Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

NCT ID: NCT01678976

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2002-04-30

Brief 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.

Detailed Description

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 BIA 2-093 + Oxcarbazepine

Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine

Group Type: EXPERIMENTAL

BIA 2-093

Intervention Type: DRUG

Tablets containing BIA 2-093 in doses of 300 and 600 mg

Oxcarbazepine

Intervention Type: DRUG

Tablets containing 300 mg and 600 mg of Trileptal®

Group 2 Oxcarbazepine + BIA 2-093

Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093

Group Type: ACTIVE_COMPARATOR

BIA 2-093

Intervention Type: DRUG

Tablets containing BIA 2-093 in doses of 300 and 600 mg

Oxcarbazepine

Intervention Type: DRUG

Tablets containing 300 mg and 600 mg of Trileptal®

Interventions

BIA 2-093

Tablets containing BIA 2-093 in doses of 300 and 600 mg

Intervention Type: DRUG

Oxcarbazepine

Tablets containing 300 mg and 600 mg of Trileptal®

Intervention Type: DRUG

Other Intervention Names

Eslicarbazepine acetate; Trileptal®

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Vaz-da-Silva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

BIAL - Portela & Cª S.A

Locations

BIAL - Portela & Cª - Human Pharmacology Unit (UFH)

S. Mamede Do Coronado, Trofa, Portugal

Countries

Portugal

Other Identifiers

BIA-2093-104

Identifier Type: -

Identifier Source: org_study_id