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Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284880
First Posted: November 6, 2014
Last Update Posted: January 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bial - Portela C S.A.
  Purpose
Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL)

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cmax - Maximum Plasma Concentration [ Time Frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period ]
    Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite

  • Tmax - Time of Occurrence of Cmax [ Time Frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period ]

    Reference - MF - marketed formulation Test - TBM - to-be-marketed

    BIA 2-005 - BIA 2-093 metabolite


  • AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification [ Time Frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period ]

    Reference - MF - marketed formulation Test - TBM - to-be-marketed

    BIA 2-005 - BIA 2-093 metabolite



Enrollment: 40
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 BIA 2-093
Subjects randomly received on period 1 and 2, either a single 400 mg tablet of ESL (MF - marketed formulation), or a single 400 mg tablet of ESL (TBM - o-be-marketed);
Drug: BIA 2-093
MF - Marketed formulation
Other Name: ESL, Eslicarbazepine acetate
Drug: BIA 2-093
TBM - to-be-marketed
Other Name: ESL, Eslicarbazepine acetate
Experimental: Group 2 BIA 2-093
Subjects randomly received on period 1 and 2, either a single 800 mg tablet of ESL (MF - marketed formulation), or a single 800 mg dose of ESL (TBM - o-be-marketed).
Drug: BIA 2-093
MF - Marketed formulation
Other Name: ESL, Eslicarbazepine acetate
Drug: BIA 2-093
TBM - to-be-marketed
Other Name: ESL, Eslicarbazepine acetate

Detailed Description:
Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects. The study consisted in 2 periods separated by a wash-out of at least 7 days between doses. To demonstrate the bioequivalence (BE) between two active product ingredient (API) sources [current API source - marketed formulation (MF) versus new API source - to-be-marketed (TBM)] of eslicarbazepine acetate (ESL)
  Eligibility

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:

  • A signed and dated informed consent form before any study-specific screening procedure was performed,
  • Healthy male or female 18 to 55 of age, inclusive,
  • Had a BMI within the range of 18 to 25 kg/m2 inclusive at screening,
  • Had a physical examination, vital signs, electrocardiogram (ECG) and routine laboratory tests within normal ranges or considered as non clinically significant (NCS) by the Investigator,
  • Non-smokers or smokers of less than 10 cigarettes per day,
  • If female, she was not of childbearing potential by reason of surgery (hysterectomy, bilateral oophorectomy or tubal ligation) or, if of childbearing potential, she had to be using one of the following effective method of contraception (intrauterine device (IUD) or abstention or condom) for the duration of the trial and had to have a negative urine pregnancy test at screening visit and upon each admission period.

Exclusion Criteria:

  • Had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue disease or disorders, or have a clinically relevant surgical history,
  • Presented any disease or condition (medical or surgical) which, in the opinion of the Investigator, that may have interfered with the absorption, distribution, metabolism or excretion of study drug,
  • Had a history of relevant atopy or any drug hypersensitivity (including known hypersensitivity to eslicarbazepine acetate or any of its excipients),
  • Had a history of alcoholism or drug abuse within 1 year before D 1,
  • Consumption of more than 50 g of ethanol per day (12.5 Centiliters [cL] glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g),
  • Use of medicines within 2 weeks of admission to first treatment period that could affect, in the Investigator's opinion, the safety of the subject,
  • Had used any investigational drug or participated in any clinical trial within 2 months of admission to first treatment period,
  • Had donated or received any blood or blood products within 2 months prior to screening,
  • Could not communicate reliably with the investigator, was unlikely to co-operate with the requirements of the study,
  • Was unwilling or unable to give written informed consent,
  • If female, was pregnant or breast-feeding,
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02284880     History of Changes
Other Study ID Numbers: BIA-2093-130
First Submitted: November 4, 2014
First Posted: November 6, 2014
Results First Submitted: December 10, 2014
Results First Posted: January 12, 2015
Last Update Posted: January 12, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Eslicarbazepine acetate
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action