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The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microginon® | Other | A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). |
|
| ESL and Microginon® | Experimental | 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eslicarbazepine acetate and Microginon® | Drug | eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period. Microginon®: single oral dose on day 14 of treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Plasma Concentration | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | 15-day |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Vaz-da-Silva | Bial Portela | 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, S. Mamede do Coronado | Porto | 4745-457 | Portugal |
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| ID | Title | Description |
|---|---|---|
| FG000 | ESL and Microginon® | 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive. eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period. Microginon®: single oral dose on day 14 of treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESL and Microginon® | 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive. eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period. Microginon®: single oral dose on day 14 of treatment period |
| 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 | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | Posted | Mean | Standard Deviation | pg/mL | 15-day |
|
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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 | ESL and Microginon® | 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive. eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period. Microginon®: single oral dose on day 14 of treatment period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Xerophthalmia | Eye disorders | MedDRA (12.0) |
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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 |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C416835 | eslicarbazepine acetate |
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|
| Microginon® | Drug | Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel) |
|
| 15-day |
| AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | 15-day |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | Posted | Mean | Standard Deviation | ng.h/mL | 15-day |
|
|
|
| Secondary | AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity | To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel). | Posted | Mean | Standard Deviation | ng.h/mL | 15-day |
|
|
|
| 0 |
| 20 |
| 18 |
| 20 |
| EG001 | Microginon® | A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel) | 0 | 20 | 8 | 20 |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) |
|
| Dry throat | Gastrointestinal disorders | MedDRA (12.0) |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (12.0) |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA (12.0) |
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| Toothache | Gastrointestinal disorders | MedDRA (12.0) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) |
|
| Vessel puncture site haematoma | General disorders | MedDRA (12.0) |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA (12.0) |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (12.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
|
| Diplopia | Nervous system disorders | MedDRA (12.0) |
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| Dizziness | Nervous system disorders | MedDRA (12.0) |
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| Headache | Nervous system disorders | MedDRA (12.0) |
|
| Somnolence | Nervous system disorders | MedDRA (12.0) |
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| Syncope | Nervous system disorders | MedDRA (12.0) |
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| Tremor | Nervous system disorders | MedDRA (12.0) |
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| Anxiety | Psychiatric disorders | MedDRA (12.0) |
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| Libido increased | Psychiatric disorders | MedDRA (12.0) |
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| Dysuria | Renal and urinary disorders | MedDRA (12.0) |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA (12.0) |
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| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) |
|
| Cheilitis | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (12.0) |
|
| Sexual activity increased | Social circumstances | MedDRA (12.0) |
|
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