Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate

Epilepsy Clinical Trial

Official title:

Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284880
• Other study ID #: BIA-2093-130
• Status: Completed
• Phase: Phase 1
• First received: November 4, 2014
• Last updated: January 7, 2015
• Start date: October 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2015
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• BIA 2-093
MF - Marketed formulation
• BIA 2-093
TBM - to-be-marketed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax - Maximum Plasma Concentration	Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite	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	No
Primary	Tmax - Time of Occurrence of Cmax	Reference - MF - marketed formulation Test - TBM - to-be-marketed; BIA 2-005 - BIA 2-093 metabolite	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	No
Primary	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	Reference - MF - marketed formulation Test - TBM - to-be-marketed; BIA 2-005 - BIA 2-093 metabolite	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	No