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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01678976
First received: August 31, 2012
Last updated: September 4, 2012
Last verified: August 2012

August 31, 2012
September 4, 2012
March 2002
April 2002   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Pharmacokinetic parameters were derived from the concentration versus time profiles after each dose in each subject: time at which the Cmax occurred (tmax)
Same as current
Complete list of historical versions of study NCT01678976 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Pharmacokinetic parameters were derived from the concentration versus time profiles after each dose in each subject:area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t)
Same as current
Number of Adverse Events reported per Patient [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient
Same as current
 
Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
  • Drug: BIA 2-093
    Tablets containing BIA 2-093 in doses of 300 and 600 mg
    Other Name: Eslicarbazepine acetate
  • Drug: Oxcarbazepine
    Tablets containing 300 mg and 600 mg of Trileptal®
    Other Name: Trileptal®
  • Experimental: BIA 2-093
    Administered in the form of tablets, given with 200 mL potable water. The dose level investigated was 900 mg for each compound.
    Intervention: Drug: BIA 2-093
  • Active Comparator: Oxcarbazepine
    Administered in the form of tablets, given with 200 mL potable water. The dose level investigated was 900 mg for each compound.
    Intervention: Drug: Oxcarbazepine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2002
April 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01678976
BIA-2093-104
No
Bial - Portela C S.A.
Bial - Portela C S.A.
Not Provided
Principal Investigator: Manuel Vaz-da-Silva, MD, PhD BIAL - Portela & Cª S.A
Bial - Portela C S.A.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP