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The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence A | Experimental | Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period |
|
| Treatment Sequence B | Experimental | Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Plasma Concentration | Maximum Observed Plasma Metformin Concentration | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax - Time of Occurrence of Cmax | time of occurrence of maximum observed plasma metformin concentration | 3 weeks |
| AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity | area under the plasma metformin concentration from time zero to infinity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Vaz-da-Silva, MD, PhD | BIAL - Portela & Ca, S.A | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Pharmacology Unit (UFH)Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, | Mamede Do Coronado | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19356391 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence A | Treatment Sequence A: Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period 850 mg metformin hydrochloride, 1200 mg ESL |
| FG001 | Treatment Sequence B | Treatment Sequence B: Metformin period followed by washout period followed by Metformin + Eslicarbazepine acetate 850 mg metformin hydrochloride, 1200 mg ESL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax - Maximum Observed Plasma Concentration | Maximum Observed Plasma Metformin Concentration | Posted | Mean | Standard Deviation | ng/mL | 3 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythropapular rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research | Bial - Portela & Cª, S.A. | +351 229 866 100 | jose.rocha@bial.com |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C416835 | eslicarbazepine acetate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| Eslicarbazepine acetate | Drug |
|
|
| 3 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Tmax - Time of Occurrence of Cmax | time of occurrence of maximum observed plasma metformin concentration | Posted | Mean | Standard Deviation | hours | 3 weeks |
|
|
|
| Secondary | AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity | area under the plasma metformin concentration from time zero to infinity | Posted | Mean | Standard Deviation | ng*h/mL | 3 weeks |
|
|
|
| 0 |
| 20 |
| 9 |
| 20 |
| EG001 | Metformin | Metformin HCl 850 mg | 0 | 20 | 5 | 20 |
| Vasovagal reaction | Nervous system disorders | MedDRA 10.0 |
|
| Constipation | General disorders | MedDRA 10.0 |
|
| Herpes labialis | Infections and infestations | MedDRA 10.0 |
|
| Right forearm ecchymosis | General disorders | MedDRA 10.0 |
|
| Recurrent vasovagal reaction | Nervous system disorders | MedDRA 10.0 |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
|
| Bilateral popliteal erythromacular rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 |
|
| Headache | Nervous system disorders | MedDRA 10.0 |
|
| Eczema aggravated | Skin and subcutaneous tissue disorders | MedDRA 10.0 |
|
| Acute gastroenteritis | Infections and infestations | MedDRA 10.0 |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 |
|
| Eyelid hematoma | Injury, poisoning and procedural complications | MedDRA 10.0 |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |