- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02273518
Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
23. oktober 2014 opdateret af: Boehringer Ingelheim
A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers
Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
18
Fase
- Fase 1
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
21 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
- Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
- Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
- Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
- The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Exclusion Criteria:
- Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
- Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
- Volunteers who participate in another study with an investigational drug within the last two months preceding the study
- Volunteers who are unable to refrain from smoking on study days
- Volunteers who smoke more than10 cigarettes (or equivalent) per day
- Volunteers who drink more than 60 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who donate blood (≥ 100 mL) within the last four weeks
- Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)
- Volunteers who suffer from any other disease or abnormality of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
- History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
Female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Asasantin ER, nuværende kommerciel formulering
|
|
Eksperimentel: Asasantin ER, new formulation I
|
|
Eksperimentel: Asasantin ER, new formulation II
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)
Tidsramme: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent peak trough fluctuation of dipyridamole in plasma (%PTF)
Tidsramme: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
Tidsramme: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Tidsramme: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)
Tidsramme: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)
Tidsramme: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Terminal half-life of the analytes in plasma (t1/2)
Tidsramme: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Percent of dose of the analytes recovered unchanged in urine (Ae%)
Tidsramme: Up to 24 hours after start of drug administration
|
Up to 24 hours after start of drug administration
|
Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)
Tidsramme: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)
Tidsramme: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with clinically relevant changes in 12-lead ECG
Tidsramme: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with clinically relevant changes in laboratory values
Tidsramme: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Number of subjects with adverse events
Tidsramme: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
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. april 2001
Primær færdiggørelse (Faktiske)
1. maj 2001
Datoer for studieregistrering
Først indsendt
23. oktober 2014
Først indsendt, der opfyldte QC-kriterier
23. oktober 2014
Først opslået (Skøn)
24. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. oktober 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. oktober 2014
Sidst verificeret
1. oktober 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9.144
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 .