Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00971295 |
Recruitment Status :
Completed
First Posted : September 3, 2009
Results First Posted : December 16, 2014
Last Update Posted : December 16, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuropathic Pain | Drug: Metformin Drug: Eslicarbazepine acetate | Phase 1 |
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 Metformin in Healthy Volunteers |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | September 2008 |

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 Name: Glucophage Drug: Eslicarbazepine acetate Other Name: 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 Name: Glucophage Drug: Eslicarbazepine acetate Other Name: Zebinix |
- Cmax - Maximum Observed Plasma Concentration [ Time Frame: 3 weeks ]Maximum Observed Plasma Metformin Concentration
- Tmax - Time of Occurrence of Cmax [ Time Frame: 3 weeks ]time of occurrence of maximum observed plasma metformin concentration
- 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

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

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): NCT00971295
Portugal | |
Human Pharmacology Unit (UFH)Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, | |
Mamede do Coronado, Portugal |
Principal Investigator: | Manuel Vaz-da-Silva, MD, PhD | BIAL - Portela & Ca, S.A |
Responsible Party: | Bial - Portela C S.A. |
ClinicalTrials.gov Identifier: | NCT00971295 |
Other Study ID Numbers: |
BIA-2093-125 |
First Posted: | September 3, 2009 Key Record Dates |
Results First Posted: | December 16, 2014 |
Last Update Posted: | December 16, 2014 |
Last Verified: | December 2014 |
eslicarbazepine acetate zebinix metformin |
Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Metformin Eslicarbazepine acetate |
Hypoglycemic Agents Physiological Effects of Drugs Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |