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- Sperimentazione clinica NCT01777516
In Vitro Interaction Between Ticagrelor and Its Active Metabolite and Their Effects on Salicylic Acid (In_vitro_PAT)
In Vitro Study to Evaluate the Pharmacodynamic Interaction Between Ticagrelor and Its Active Metabolite (AR-C124910XX) and Their Effects on the Pharmacodynamics of Salicylic Acid : Concentration-antiplatelet Effect Relationships
This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic acid. The study consist of two parts of in-vitro study as follows;
- Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite.
- Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite and their effect on the pharmacodynamics of salicylic acid on platelet aggregation tests with the agonist of arachidonic acid.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic acid. The study consist of two parts of in-vitro study as follows;
- Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite. Platelet aggregation tests with the agonist of adenosine diphosphate(ADP) will be assessed on the in-vitro mixtures of blank plasma and randomized paired concentrations of ticagrelor + AR-C124910XX.
- Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite. Platelet aggregation tests with the agonist of arachidonic acid will be assessed on the in-vitro mixtures of blank plasma plus randomized paired concentrations of ticagrelor and AR-C124910XX and the invitro mixtures with blank plasma and ticagrelor + AR-C124910XX + salicylic acid.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Seoul, Corea, Repubblica di, 138-736
- Asan Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Subjects with body weight more than 50 kg and within 20% of the ideal body weight: ideal body weight = (height[cm] - 100)*0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Exclusion Criteria:
- Subjects who have a history or presence of any clinically significant diseases.
- Subjects who have any congenital or acquired haematological diseases.
- Subjects who had whole blood donation within the last 2 months and component blood donation within the last month.
- Subject who took any concomitant medication including non-steroidal antiinflammatory drugs(NASIDs) and vitamins currently or within 7 days prior to blood sampling.
Piano di studio
Come è strutturato lo studio?
Coorti e interventi
Gruppo / Coorte |
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healthy volunteers
1 group with no treatment : They provide the blank plasma to be used at in vitro study.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Platelet aggregation(%) of the in vitro mixtures of blank plasma and drugs of the randomized paired concentrations
Lasso di tempo: The tolerability of volunteers after blood sampling will be followed for the duration of hospital stay, an expected average of 5 hours.
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Plasma which were collected from healthy volunteers were used to make mixtures of drugs, ticagrelor, AR-C124910XX and salicylic acid.
ADP and arachidonic acid were used as the agonists of platelet aggregation.
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The tolerability of volunteers after blood sampling will be followed for the duration of hospital stay, an expected average of 5 hours.
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Hyeong-Seok Lim, M.D., PhD, Asan Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AsanMC_CPT_PAT_2012
- A070001 (Altro numero di sovvenzione/finanziamento: Korea National Enterprise For Clinical Trials)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .