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Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers

23 oktober 2014 bijgewerkt door: 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

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

18

Fase

  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Asasantin ER, huidige commerciële formulering
Experimenteel: Asasantin ER, new formulation I
Experimenteel: Asasantin ER, new formulation II

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)
Tijdsspanne: 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)
Tijdsspanne: Up to 48 hours after start of drug administration
Up to 48 hours after start of drug administration

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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%)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: up to 8 days after last study drug administration
up to 8 days after last study drug administration
Number of subjects with adverse events
Tijdsspanne: up to 8 days after last study drug administration
up to 8 days after last study drug administration

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2001

Primaire voltooiing (Werkelijk)

1 mei 2001

Studieregistratiedata

Eerst ingediend

23 oktober 2014

Eerst ingediend dat voldeed aan de QC-criteria

23 oktober 2014

Eerst geplaatst (Schatting)

24 oktober 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

24 oktober 2014

Laatste update ingediend die voldeed aan QC-criteria

23 oktober 2014

Laatst geverifieerd

1 oktober 2014

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 9.144

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