- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02273518
Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
23 octobre 2014 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
18
Phase
- La phase 1
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans à 50 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Asasantin ER, formulation commerciale actuelle
|
|
|
Expérimental: Asasantin ER, new formulation I
|
|
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Expérimental: Asasantin ER, new formulation II
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)
Délai: 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)
Délai: Up to 48 hours after start of drug administration
|
Up to 48 hours after start of drug administration
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Maximum concentration of the analytes in plasma at steady state (Cmax,ss)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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%)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
|
Number of subjects with adverse events
Délai: up to 8 days after last study drug administration
|
up to 8 days after last study drug administration
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2001
Achèvement primaire (Réel)
1 mai 2001
Dates d'inscription aux études
Première soumission
23 octobre 2014
Première soumission répondant aux critères de contrôle qualité
23 octobre 2014
Première publication (Estimation)
24 octobre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
24 octobre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 octobre 2014
Dernière vérification
1 octobre 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 9.144
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