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

Phase 1

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: Metformin; Drug: Eslicarbazepine acetate

• Registration Number: NCT00971295
• Lead Sponsor: Bial - Portela C S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2007-12
• Study Completion: 2008-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Status Verified: 2014-12
• Results First Submitted: 2014-12-04
• Results First Submitted QC: 2014-12-15
• Last Update Submitted: 2014-12-15
• Results First Posted: 2014-12-16
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence A	Metformin	Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period
Treatment Sequence A	Eslicarbazepine acetate	Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period
Treatment Sequence B	Metformin	Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period
Treatment Sequence B	Eslicarbazepine acetate	Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Plasma Concentration	3 weeks	Maximum Observed Plasma Metformin Concentration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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