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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2002

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.

Interventions

  • Drug: BIA 2-093
    • Tablets containing BIA 2-093 in doses of 300 and 600 mg
  • Drug: Oxcarbazepine
    • Tablets containing 300 mg and 600 mg of Trileptal®

Arms, Groups and Cohorts

  • Experimental: Group 1 BIA 2-093 + Oxcarbazepine
    • Period 1 – Subjects recieved 900 mg of BIA 2-093 Period 2 – Subjects recieved 900 mg of oxcarbazepine
  • Active Comparator: Group 2 Oxcarbazepine + BIA 2-093
    • Period 1 – Subjects recieved 900 mg of oxcarbazepine Period 2 – Subjects recieved 900 mg of BIA 2-093

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Drug Concentration (Cmax)
    • Time Frame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
    • Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.

Secondary Measures

  • Area Under the Plasma Concentration Versus Time Curve (AUC)
    • Time Frame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
    • Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bial – Portela C S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Manuel Vaz-da-Silva, MD, PhD, Principal Investigator, BIAL – Portela & Cª S.A

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