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

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 1

Locations

Portugal

Study Type

Interventional

Intervention

BIA 2-093

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CEB - Centre for Bioavailability Studies, AIBILI

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

st period - 16 mL oral suspension 50 mg/mL nd period - Four 200 mg tablets rd period - One 800 mg tablet

st period - One 800 mg tablet nd period - 16 mL oral suspension 50 mg/mL rd period - Four 200 mg tablets

st period - Four 200 mg tablets nd period - One 800 mg tablet rd period - 16 mL oral suspension 50 mg/mL

Outcomes

Primary Outcome Measures

Cmax - the Maximum Plasma Concentration

Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005

Tmax - the Time of Occurrence of Cmax

Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005

AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time

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

AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity

AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005

Secondary Outcome Measures

Full Information

NCT ID

NCT02279667

First Posted

October 29, 2014

Last Updated

December 31, 2014

Sponsor

Bial - Portela C S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02279667

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

March 2004 (Actual)

Study Completion Date

March 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bial - Portela C S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

st period - 16 mL oral suspension 50 mg/mL nd period - Four 200 mg tablets rd period - One 800 mg tablet

Arm Title

Group B

Arm Type

Experimental

Arm Description

st period - One 800 mg tablet nd period - 16 mL oral suspension 50 mg/mL rd period - Four 200 mg tablets

Arm Title

Group C

Arm Type

Experimental

Arm Description

st period - Four 200 mg tablets nd period - One 800 mg tablet rd period - 16 mL oral suspension 50 mg/mL

Intervention Type

Drug

Intervention Name(s)

BIA 2-093

Other Intervention Name(s)

ESL, Eslicarbazepine acetate

Intervention Description

oral suspension 50 mg/mL

Intervention Type

Drug

Intervention Name(s)

BIA 2-093

Other Intervention Name(s)

ESL, Eslicarbazepine acetate

Intervention Description

200 mg tablet

Intervention Type

Drug

Intervention Name(s)

BIA 2-093

Other Intervention Name(s)

ESL, Eslicarbazepine acetate

Intervention Description

800 mg tablet

Primary Outcome Measure Information:

Title

Cmax - the Maximum Plasma Concentration

Description

Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005

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

Title

Tmax - the Time of Occurrence of Cmax

Description

Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005

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

Title

AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time

Description

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

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

Title

AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity

Description

AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

CEB - Centre for Bioavailability Studies, AIBILI

City

Azinhaga de Santa Comba - Celas

State/Province

Coimbra

Country

Portugal

12. IPD Sharing Statement

Learn more about this trial

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

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