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

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ClinicalTrials.gov Identifier: NCT02777671
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 Drug: Gliclazide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers
Study Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Period 1 - BIA 2-093 + Gliclazide Period 2 - Gliclazide
Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate

Drug: Gliclazide
tablets containing gliclazide 80 mg (Diamicron® 80 mg)

Experimental: Group B
Period 1 - Gliclazide Period 2 - BIA 2-093 + Gliclazide
Drug: BIA 2-093
Other Name: ESL, Eslicarbazepine acetate

Drug: Gliclazide
tablets containing gliclazide 80 mg (Diamicron® 80 mg)




Primary Outcome Measures :
  1. Cmax [ Time Frame: before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose ]
    Maximum plasma concentration (Cmax) of Gliclazide following a single oral dose of 80 mg administered alone

  2. Tmax [ Time Frame: before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose ]
    Time to maximum observed concentration (Tmax) of Gliclazide following a single oral dose of 80 mg administered alone

  3. AUC0-12 [ Time Frame: before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose ]
    Area under the plasma concentration-time curve over 12 hours (AUC0-12) of Gliclazide following a single oral dose of 80 mg administered alone

  4. AUC0-∞ [ Time Frame: before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose ]
    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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777671


Locations
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Portugal
Human Pharmacology Unit
S. Mamede do Coronado, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02777671    
Other Study ID Numbers: BIA-2093-126
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gliclazide
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs