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

NCT00971295 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-125
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cmax - Maximum Observed Plasma Concentration

  Maximum Observed Plasma Metformin Concentration

  3 weeks

Secondary Outcomes (2)

• Tmax - Time of Occurrence of Cmax

  3 weeks

• AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity

  3 weeks

Study Arms (2)

Treatment Sequence A

EXPERIMENTAL

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

Drug: Metformin; Drug: Eslicarbazepine acetate

Treatment Sequence B

EXPERIMENTAL

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

Drug: Metformin; Drug: Eslicarbazepine acetate

Interventions

Metformin 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

Also known as: Glucophage

Treatment Sequence A; Treatment Sequence B

Eslicarbazepine acetate DRUG

Also known as: Zebinix

Treatment Sequence A; Treatment Sequence B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

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

Mamede Do Coronado, Portugal

Location

Related Publications (1)

• 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.

  PMID: 19356391 RESULT

MeSH Terms

Conditions

Neuralgia

Interventions

Metformin; eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Study Officials

• Manuel Vaz-da-Silva, MD, PhD

  BIAL - Portela & Ca, S.A

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: September 1, 2008
• Last Updated: December 16, 2014
• Results First Posted: December 16, 2014

Record last verified: 2014-12

Locations

PT (1)