Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers

NCT02777671 | Completed Phase 1

• 1 other identifier: BIA-2093-126
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre, randomised, open-label, two-way crossover study to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the pharmacokinetics of gliclazide.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (4)

• Cmax

  Maximum plasma concentration (Cmax) of Gliclazide following a single oral dose of 80 mg administered alone

  before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose

• Tmax

  Time to maximum observed concentration (Tmax) of Gliclazide following a single oral dose of 80 mg administered alone

  before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose

• AUC0-12

  Area under the plasma concentration-time curve over 12 hours (AUC0-12) of Gliclazide following a single oral dose of 80 mg administered alone

  before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose

• AUC0-∞

  Area under the concentration-time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-∞) of Gliclazide following a single oral dose of 80 mg administered alone

  before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose

Study Arms (2)

Group A

EXPERIMENTAL

Period 1 - BIA 2-093 + Gliclazide Period 2 - Gliclazide

Drug: BIA 2-093; Drug: Gliclazide

Group B

EXPERIMENTAL

Period 1 - Gliclazide Period 2 - BIA 2-093 + Gliclazide

Drug: BIA 2-093; Drug: Gliclazide

Interventions

BIA 2-093 DRUG

Also known as: ESL, Eslicarbazepine acetate

Group A; Group B

Gliclazide DRUG

tablets containing gliclazide 80 mg (Diamicron® 80 mg)

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects aged between 18 and 45 years, inclusive.
• Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
• Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
• Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
• Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
• Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day.
• Able and willing to give written informed consent.
• (If female) Not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.
• (If female) Negative urine pregnancy test at screening and admission to each treatment period.

You may not qualify if:

• 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.
• Clinically relevant surgical history.
• History of relevant atopy or drug hypersensitivity.
• History of alcoholism or drug abuse.
• Consumed more than 14 units of alcohol a week.
• Significant infection or known inflammatory process at screening or admission to each treatment period.
• Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
• Used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
• Used any investigational drug or participated in any clinical trial within 6 months prior to screening.
• Participated in more than 2 clinical trials within the 12 months prior to screening.
• Donated or received any blood or blood products within the 3 months prior to screening.
• Vegetarians, vegans or with medical dietary restrictions.
• Could not communicate reliably with the investigator.
• Unlikely to co-operate with the requirements of the study.
• Unwilling or unable to give written informed consent.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Human Pharmacology Unit

S. Mamede Do Coronado, 4745-457, Portugal

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate; Gliclazide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 19, 2016
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

PT (1)