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Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate

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ClinicalTrials.gov Identifier: NCT02288312
Recruitment Status : Completed
First Posted : November 11, 2014
Results First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 Phase 1

Detailed Description:
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard meal in one period, and following at least 10 hours of fasting in two periods.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate Market Formulation in Healthy Volunteers
Study Start Date : May 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIA 2-093 800 mg fasting
Tablets 800 mg. Administration:Oral.
Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate

Experimental: BIA 2-093 800 mg fed
Tablets 800 mg. Administration:Oral.
Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate

Experimental: BIA 2-093 400 mg
Tablets 2 x 400 mg. Administration:Oral.
Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate




Primary Outcome Measures :
  1. Cmax (BIA 2-005) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose. ]
    Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)


Secondary Outcome Measures :
  1. AUC0-t (BIA 2-005) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose. ]
    AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)

  2. Tmax (BIA 2-005) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose. ]
    tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)

  3. AUC0-∞ (BIA 2-005) [ Time Frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose. ]
    AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects aged between 18 and 55 years, inclusive.
  • Subjects of body mass index (BMI, kg/m2) within the normal range [4], i.e., between 18.50 and 24.99, inclusive.
  • Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG.
  • Subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
  • Subjects who had negative tests for HBsAg, anti-HCVAb and anti- HIV-1 and HIV-2 Ab at screening.
  • Subjects who had a negative screen for alcohol and drugs of abuse at screening.
  • Subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission.
  • Subjects who were able and willing to give written informed consent.
  • (If female) She was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner).
  • (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria, or
  • Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, 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 drug hypersensitivity.
  • Subjects who had a history of alcoholism or drug abuse.
  • Subjects who consumed more than 14 units of alcohol a week.
  • Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
  • Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
  • Subjects who had previously received eslicarbazepine acetate (ESL, BIA 2-093).
  • Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
  • Subjects who were vegetarians, vegans or have 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.
  • (If female) She was pregnant or breast-feeding.
  • (If female) She was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02288312    
Other Study ID Numbers: BIA-2093-117
First Posted: November 11, 2014    Key Record Dates
Results First Posted: January 8, 2015
Last Update Posted: January 8, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action