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
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: BIA 2-093
Drug: Oxcarbazepine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome 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 ] [ 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)


Secondary Outcome 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 ] [ 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)


Other Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: March 2002
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: BIA 2-093
Tablets containing BIA 2-093 in doses of 300 and 600 mg
Other Name: Eslicarbazepine acetate
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.
Drug: Oxcarbazepine
Tablets containing 300 mg and 600 mg of Trileptal®
Other Name: Trileptal®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01678976

Locations
Portugal
BIAL - Portela & Cª - Human Pharmacology Unit (UFH)
S. Mamede do Coronado, Trofa, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Manuel Vaz-da-Silva, MD, PhD BIAL - Portela & Cª S.A
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01678976     History of Changes
Other Study ID Numbers: BIA-2093-104
Study First Received: August 31, 2012
Last Updated: September 4, 2012
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Eslicarbazepine acetate
Epilepsy
Oxcarbazepine

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carbamazepine
Eslicarbazepine acetate
Oxcarbazepine
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Tranquilizing Agents
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014