- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01303445
Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers
27. november 2013 opdateret af: Boehringer Ingelheim
Drug-drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-label, Randomised, Crossover Study)
The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when administered every 12 hours at steady state.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Purpose:
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arizona
-
Tempe, Arizona, Forenede Stater
- 9.197.001 Boehringer Ingelheim Investigational Site
-
-
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 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
Healthy males and females according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure(BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests
- BMI >18.5 and BMI <32 kg/m2 (Body Mass Index)
Exclusion criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance in the opinion of the PI
- Any evidence of a clinically relevant concomitant disease
- Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, or hematologic (including a history of abnormal bruising) disorders in the opinion of the PI
- Surgery of the gastrointestinal tract that might impair drug absorption
- Clinically significant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to study drugs or its excipients, or reactions to related drugs [e.g., non-steroidal anti-inflammatory drugs])
- Intake of drugs with a long half-life (¿24 hours) within one month, or less than 10 half lives of the respective drug, prior to study drug administration or during the trial
- Use of drugs which might reasonably influence the results of the trial (including OTC antacids) based on the knowledge at the time of protocol preparation within 14 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Tobacco use within the 90 days prior to check-in and throughout the study
- Alcohol abuse within the past 2 years
- Drug abuse within the past 2 years
- Blood donation or other significant blood loss within 56 days (inclusive) prior to screening, or plasma donation within 7 days (inclusive) prior to study drug administration, or during the trial
- Excessive physical activities (within one week prior to first drug administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance in the opinion of the PI; including positive virology, or urine drug screen, or positive fecal occult blood test
- Inability to comply with dietary regimen of trial site
- In the opinion of the investigator it would be in the best interest of the subject to be excluded from participation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Treatment A
Aggrenox alone
|
Aggrenox 1 capsule twice daily for 7 days
|
Eksperimentel: Treatment B
Aggrenox and omeprazole
|
Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
|
Aktiv komparator: Treatment C
Omeprazole alone
|
omeprazole 80 once daily for 7 days
|
Eksperimentel: Treatment D
Aggrenox and omeprazole
|
Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Plasma Dipyridamole Maximum Concentration (Cmax)
Tidsramme: 7 days
|
Maximum measured concentration of dipyridamole in plasma
|
7 days
|
Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)
Tidsramme: 7 days
|
Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state
|
7 days
|
Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)
Tidsramme: 7 days
|
IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
|
7 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Plasma Dipyridamole Minimum Concentration (Cmin)
Tidsramme: 7 days
|
Minimum measured concentration of dipyridamole in plasma
|
7 days
|
Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)
Tidsramme: 7 days
|
IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
|
7 days
|
Percentage Peak-to-trough Fluctuation (%PTF)
Tidsramme: 7 days
|
PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.
|
7 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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 2011
Primær færdiggørelse (Faktiske)
1. april 2011
Datoer for studieregistrering
Først indsendt
23. februar 2011
Først indsendt, der opfyldte QC-kriterier
23. februar 2011
Først opslået (Skøn)
24. februar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. december 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. november 2013
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9.197
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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