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

NCT ID: NCT00971295

Last Updated: 2014-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-09-30

Brief Summary

The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.

Conditions

Neuropathic Pain

Keywords

eslicarbazepine acetate; zebinix; metformin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Sequence A

Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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

Eslicarbazepine acetate

Intervention Type: DRUG

Treatment Sequence B

Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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

Eslicarbazepine acetate

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

Eslicarbazepine acetate

Intervention Type: DRUG

Other Intervention Names

Glucophage; Zebinix

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Vaz-da-Silva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

BIAL - Portela & Ca, S.A

Locations

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

Mamede Do Coronado, , Portugal

Countries

Portugal

References

Rocha JF, Vaz-da-Silva M, Almeida L, Falcao A, Nunes T, Santos AT, Martins F, Fontes-Ribeiro C, Macedo T, Soares-da-Silva P. Effect of eslicarbazepine acetate on the pharmacokinetics of metformin in healthy subjects. Int J Clin Pharmacol Ther. 2009 Apr;47(4):255-61. doi: 10.5414/cpp47255.

Reference Type: RESULT

PMID: 19356391 (View on PubMed)

Other Identifiers

BIA-2093-125

Identifier Type: -

Identifier Source: org_study_id