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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777671
• Other study ID #: BIA-2093-126
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2016
• Last updated: May 17, 2016
• Start date: October 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2016
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Subjects were eligible for the study if they fulfilled all of the following inclusion criteria:

• 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.

Exclusion Criteria:

Subjects were not eligible for the study if they fulfilled any of the following exclusion criteria:

• 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.

• (If female) Pregnant or breast-feeding.

• (If female) Of childbearing potential and she did not use an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• BIA 2-093

• Gliclazide
tablets containing gliclazide 80 mg (Diamicron® 80 mg)

Locations

Country	Name	City	State
Portugal	Human Pharmacology Unit	S. Mamede do Coronado

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	AUC0-8	Area under the concentration-time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-8) 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	No