Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I clinical trial in healthy volunteers comparing the effect of lysine acetylsalicylate or aspirin on platelet function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: David Vivas
• Collaborator: St Carlos Hospital, Madrid, Spain
• Treatments: Acetylsalicylic acid lysinate; Aspirin; Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• Age 18-60 years.

• BMI> 19kg/m2 and <29kg/m2.

• Women of childbearing potential who are committed to use a medically effective contraception during their participation in the study, except hormonal contraceptives.

• Percentage of inhibition of platelet aggregation after stimulation with high basal 20 mM ADP and arachidonic acid 1.5 mM> 70%.

• No clinically significant deviation on physical examination, ECG or laboratory values in laboratory tests.

• Signed informed consent

Exclusion Criteria:

• Smoking

• Drug abuse

• Pregnant or lactating

• Infection with Hepatitis B or C, or HIV

• Known drug allergies

• Family history of blood disorders or coagulation.

• History of disease that alters the absorption, metabolism or excretion of drugs, including jaundice.

• Personal history of bleeding and / or blood dyscrasias (especially hemophilia, hypoprothrombinemia), including vascular malformations reasonable suspicion.

• History of any medically relevant condition

• Background of major surgery in the last 3 months

• Prescription of chronic medication in the 14 days prior to study participation.

• Participation in another study involving the administration of an investigational product in the last 4 months or a product already on the market in the last three months.