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Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093

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ClinicalTrials.gov Identifier: NCT02279667
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.

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

Detailed Description:

Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were to be recruited and entered the study. Therefore, a total of 18 subjects were enrolled.

Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and 45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10 cigarettes or equivalent per day.

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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: Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093 in Healthy Volunteers
Study Start Date : February 2004
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
  1. st period - 16 mL oral suspension 50 mg/mL
  2. nd period - Four 200 mg tablets
  3. rd period - One 800 mg tablet
Drug: BIA 2-093
oral suspension 50 mg/mL
Other Name: ESL, Eslicarbazepine acetate

Drug: BIA 2-093
200 mg tablet
Other Name: ESL, Eslicarbazepine acetate

Drug: BIA 2-093
800 mg tablet
Other Name: ESL, Eslicarbazepine acetate

Experimental: Group B
  1. st period - One 800 mg tablet
  2. nd period - 16 mL oral suspension 50 mg/mL
  3. rd period - Four 200 mg tablets
Drug: BIA 2-093
oral suspension 50 mg/mL
Other Name: ESL, Eslicarbazepine acetate

Drug: BIA 2-093
200 mg tablet
Other Name: ESL, Eslicarbazepine acetate

Drug: BIA 2-093
800 mg tablet
Other Name: ESL, Eslicarbazepine acetate

Experimental: Group C
  1. st period - Four 200 mg tablets
  2. nd period - One 800 mg tablet
  3. rd period - 16 mL oral suspension 50 mg/mL
Drug: BIA 2-093
oral suspension 50 mg/mL
Other Name: ESL, Eslicarbazepine acetate

Drug: BIA 2-093
200 mg tablet
Other Name: ESL, Eslicarbazepine acetate

Drug: BIA 2-093
800 mg tablet
Other Name: ESL, Eslicarbazepine acetate




Primary Outcome Measures :
  1. Cmax - the Maximum Plasma Concentration [ Time Frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose ]
    Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005

  2. Tmax - the Time of Occurrence of Cmax [ Time Frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose ]
    Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005

  3. AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time [ Time Frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose ]
    AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005

  4. AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [ Time Frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose ]
    AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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, vital signs and 12-lead ECG at screening.
  • Subjects who had clinical laboratory tests clinically acceptable at screening.
  • 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.
  • Subjects who were non-smokers or who smoke less than 10 cigarettes or equivalent per day.
  • Subjects who were able and willing to give written informed consent.
  • (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: doublebarrier, intra-uterine device or abstinence.
  • (If female) She had a negative pregnancy test at screening and admission to each study period.

Exclusion Criteria:

  • Subjects who do not conform to the above inclusion criteria, or
  • Subjects who have 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 have a clinically relevant surgical history.
  • Subjects who have a clinically relevant family history.
  • Subjects who have a history of relevant atopy.
  • Subjects who have a history of any drug hypersensitivity.
  • Subjects who have a history of alcoholism or drug abuse.
  • Subjects who consume more than 14 units of alcohol a week.
  • Subjects who have a significant infection or known inflammatory process on screening and/or first admission.
  • Subjects who have acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
  • Subjects who have used medicines within 2 weeks of admission to first period.
  • Subjects who have participated in any clinical trial within 3 months prior to screening.
  • Subjects who have previously received BIA 2-093.
  • Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to screening.
  • Subjects who are vegetarians, vegans and/or have medical dietary restrictions.
  • Subjects who cannot communicate reliably with the investigation team.
  • Subjects who are unlikely to co-operate with the requirements of the study.
  • Subjects who are unwilling or unable to give written informed consent.
  • (If female) She is pregnant or breast-feeding.
  • (If female) She is of childbearing potential and she does not use an approved effective contraceptive method or she uses oral contraceptives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279667


Locations
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Portugal
CEB - Centre for Bioavailability Studies, AIBILI
Azinhaga de Santa Comba - Celas, Coimbra, Portugal
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02279667    
Other Study ID Numbers: BIA-2093-109
First Posted: October 31, 2014    Key Record Dates
Results First Posted: January 1, 2015
Last Update Posted: January 1, 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