Clinical trial NCT02284880: Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate
Official title: Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2014-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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)

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 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,

Primary outcomes:
measure: Cmax - Maximum Plasma Concentration
timeFrame: 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
measure: Tmax - Time of Occurrence of Cmax
timeFrame: 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
measure: 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
timeFrame: 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
Secondary outcomes:
Other outcomes:
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