The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093

Overview

The purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of BIA 2-093 in healthy volunteers.

Full Title of Study: “The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093 in Healthy Male Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2001

Detailed Description

Single centre, open label, randomized, two-way crossover study in 12 healthy male volunteers. The study consisted of 2 periods separated by a washout period of 14 days or more. On each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.

Interventions

  • Drug: BIA 2-093

Arms, Groups and Cohorts

  • Experimental: Single Group
    • the volunteers received a single 800 mg BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting. Fed and fasting periods were separated by a washout period

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Observed Plasma Concentration (Cmax)
    • Time Frame: 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 of BIA 2-093

Secondary Measures

  • Time of Occurrence of Cmax (Tmax)
    • Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
    • Time of occurrence of Cmax of BIA 2-093
  • Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t)
    • Time Frame: 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 from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) of BIA 2-093
  • Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo)
    • Time Frame: 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 from time zero to infinity (AUC0-oo) of BIA 2-093

Participating in This Clinical Trial

Inclusion Criteria

Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:

  • Male 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, EEG, and 12-lead ECG. – Subjects who had clinical laboratory tests clinically acceptable to the investigator. – Subjects who were negative for HBsAg, 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. 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 an acute infection such as influenza at the time of screening and/or admission. – Subjects who had used prescription drugs within four 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 two 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 two 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.

Gender Eligibility: Male

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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.