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
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