- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02281448
Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.
28. november 2014 opdateret af: Bial - Portela C S.A.
Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers
Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing with an oral once daily dose of 1200 mg of BIA 2-093
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days separated by a washout period of at least 3 weeks.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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S. Mamede do Coronado, Portugal, 4045-457
- Bial - Portela & Cª, S.A.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Pre-menopausal female;
- Able and willing to give written informed consent;
- Aged 18 to 40 years, inclusive;
- Not pregnant or breast-feeding;
- Body mass index (BMI) between 19 and 30 kg/m2, inclusive;
- Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG;
- Clinical laboratory tests with clinically acceptable results at screening and admission to the first period;
- Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;
- Negative test for drugs of abuse at screening;
- Non-smoker or smokes less than 10 cigarettes or equivalent per day;
- Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit;
- Negative pregnancy test at screening and admission to the first period.
Exclusion Criteria:
- Had any contra-indication to the use of oral contraceptives;
- Had experienced notable adverse events while on any oral contraceptive;
- Had a history of alcoholism or drug abuse;
- Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
- Had acute gastrointestinal symptoms at the time of screening or admission to the first period;
- Had a significant infection or inflammatory process at the time of screening or admission to the first period;
- Had a relevant surgical history;
- Had a relevant family history;
- Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine);
- Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period;
- Consumed more than 14 units of alcohol a week;
- Had participated in any clinical trial within 3 months prior to screening;
- Had previously received BIA 2-093;
- Had donated or received any blood or blood products within 2 months prior to screening;
- Was unlikely to co-operate with the requirements of the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Treatment sequence A
oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive
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Andet: Treatment sequence B
oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Tidsramme: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
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Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
|
Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cmax
Tidsramme: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
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Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
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pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
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Tmax
Tidsramme: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
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Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
|
pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
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AUC0-t
Tidsramme: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
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AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
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pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2005
Primær færdiggørelse (Faktiske)
1. maj 2005
Studieafslutning (Faktiske)
1. maj 2005
Datoer for studieregistrering
Først indsendt
30. oktober 2014
Først indsendt, der opfyldte QC-kriterier
30. oktober 2014
Først opslået (Skøn)
2. november 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. november 2014
Sidst verificeret
1. november 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Epilepsi
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Membrantransportmodulatorer
- Antikonvulsiva
- Spændingsstyret natriumkanalblokkere
- Natriumkanalblokkere
- Reproduktive kontrolmidler
- Præventionsmidler, kvinder
- Præventionsmidler
- Præventionsmidler, Oral
- Eslicarbazepinacetat
- Præventionsmidler, orale, kombinerede
Andre undersøgelses-id-numre
- BIA-2093-114
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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