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

December 15, 2014 updated by: Bial - Portela C S.A.
The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Mamede do Coronado, Portugal
        • Human Pharmacology Unit (UFH)Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Sequence A
Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period
Drug: Metformin
850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days
Other Names:
  • Glucophage
Drug: Eslicarbazepine acetate
Other Names:
  • Zebinix
EXPERIMENTAL: Treatment Sequence B
Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period
Drug: Metformin
850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days
Other Names:
  • Glucophage
Drug: Eslicarbazepine acetate
Other Names:
  • Zebinix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax - Maximum Observed Plasma Concentration
Time Frame: 3 weeks
Maximum Observed Plasma Metformin Concentration
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax - Time of Occurrence of Cmax
Time Frame: 3 weeks
time of occurrence of maximum observed plasma metformin concentration
3 weeks
AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity
Time Frame: 3 weeks
area under the plasma metformin concentration from time zero to infinity
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bial - Portela C S.A.

Investigators

  • Principal Investigator: Manuel Vaz-da-Silva, MD, PhD, BIAL - Portela & Ca, S.A

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (ESTIMATE)

September 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIA-2093-125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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