Neuropathic Pain
Conditions
Keywords
eslicarbazepine acetate, zebinix, metformin
Brief summary
The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.
Interventions
DRUGMetformin
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
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax - Maximum Observed Plasma Concentration | 3 weeks | Maximum Observed Plasma Metformin Concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity | 3 weeks | area under the plasma metformin concentration from time zero to infinity |
| Tmax - Time of Occurrence of Cmax | 3 weeks | time of occurrence of maximum observed plasma metformin concentration |
Countries
Portugal
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metformin + ESL Metformin HCl 850 mg, ESL 1200 mg
Metformin + eslicarbazepine: 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Metformin + ESL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 20 | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Cmax - Maximum Observed Plasma Concentration
Maximum Observed Plasma Metformin Concentration
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metformin + ESL | Cmax - Maximum Observed Plasma Concentration | 1091 ng/mL | Standard Deviation 27.6 |
| Metformin | Cmax - Maximum Observed Plasma Concentration | 1224 ng/mL | Standard Deviation 21.9 |
Secondary
AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity
area under the plasma metformin concentration from time zero to infinity
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metformin + ESL | AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity | 7362 ng*h/mL | Standard Deviation 26.7 |
| Metformin | AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity | 7688 ng*h/mL | Standard Deviation 21.4 |
Secondary
Tmax - Time of Occurrence of Cmax
time of occurrence of maximum observed plasma metformin concentration
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metformin + ESL | Tmax - Time of Occurrence of Cmax | 2.66 hours | Standard Deviation 46.9 |
| Metformin | Tmax - Time of Occurrence of Cmax | 2.53 hours | Standard Deviation 40.4 |