E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers
(Prophylaxis of arterial thrombosis) |
Raske frivillige
(Profylakse af arterielle tromber) |
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E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers
(Prevention of cardiovascular disease) |
Raske frivillige
(Forebyggelse af hjertekar-sygdom ) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Investigate the correlation between acetylsalicylic acid and salicylic acid pharmacokinetics and the platelet inhibition determined by the following parameters: Parameters for assesing acetylsalicylic acid and salicylic acid pharmacokinetics: - Maximal concentration - Areal under the concentration curve - Time above a certain concentration - Time for maximal concentration Parameters to assess the platelet inhibition: - Platelet inhibition at the time of maximal acetylsalicylic acid and salicylic acid concentrations - Maximal platelet inhibition - Areal under the effect curve - Platelet inhibition 24 hours after acetylsalicylic acid intake (through effect) - Time for maximal platelet inhibition.
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Undersøge korrelationen mellem acetylsalicylsyres og salicylats farmakokinetik og trombocythæmning bedømt på følgende parametre: Parametre til vurdering af acetylsalicylsyres og salicylats farmakokinetik: - Maksimale koncentration - Arealet under koncentrationskurven - Tid over en given koncentration - Tidspunkt for maksimale koncentration Parametre til vurdering af trombocythæmning: - Trombocythæmning til tidspunktet for maksimale acetylsalicylsyre og salicylat koncentrationer - Maksimale trombocythæmning - Arealet under effektkurven - Trombocythæmning 24 timer efter acetylsalicylsyre indtag (daleffekt) - Tidspunkt for maksimal trombocythæmning.
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E.2.2 | Secondary objectives of the trial |
Determine if treatment with enteric coated acetylsalicylic acid (Hjertealbyl®) and non enteric coated acetylsalicylic acid (Hjertemagnyl®) result in the same degree of platelet inhibition, and determine if assessment of treatment effect must be made at different times dependent on formulation. |
Afklare om behandling med entero- og non-enterocoated acetylsalicylsyre (henholdsvis Hjertealbyl® og Hjertemagnyl®) medfører samme grad af trombocythæmning, samt om vurdering af behandlingseffekt skal foretages på forskellige tidspunkter afhængigt af formulering. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. ≥18 years. 2. Capable of giving informed consent. 3. For women of childbearing potential: Use of safe contraception through the entire study period. |
1. ≥18 år. 2. I stand til at give informeret samtykke. 3. For kvinder i fertil alder: anvendelse af sikker prævention i hele forsøgsperioden.
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E.4 | Principal exclusion criteria |
1. Established or assumed intolerans towards acetylsalicylic acid 2. Medical history of heart, liver or kidney disease 3. Medical history of haemophilia 4. Intake of medicine that affects the platelets or the turnover of platelets (e.g. NSAID) within the last week before study enrollment. 5. Antithrombotic treatment. 6. Current or previous medical history of gastrointestinal bleeding. 7. Thrombocytopenia (<150 x 109/l). 8. Pregnancy or current wish to achieve pregnancy. |
1. Kendt eller formodet overfølsomhed overfor acetylsalicylsyre. 2. Kendt hjerte, lever- eller nyresygdom. 3. Kendt blødersygdom. 4. Indtag af medicin, der kan påvirke trombocytterne eller omsætningen af disse (f.eks. NSAID) indenfor den sidste uge før deltagelse. 5. Antitrombotisk behandling. 6. Aktuelt eller tidligere tilfælde af gastrointestinal blødning. 7. Trombocytopeni (<150 x 109/l). 8. Graviditet eller aktuelt forsøg på at opnå graviditet.
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E.5 End points |
E.5.1 | Primary end point(s) |
- Maximal acetylsalicylic acid concentration. - Platelet inhibition at the time of maximal acetylsalicylic acid concentration. |
- Maksimale acetylsalicylsyre koncentration - Trombocythæmning til tidspunktet for maksimale acetylsalicylsyre koncentration.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary end points will be evaluated after the collection of all data. No interim analyses will be performed.
Blood for measurement of the primary end points will be collected at day 7 and day 8 after intake of the 7 th. dose of acetylsalicylic acid, where we will perform serial measurements of acetylsalicylic acid concentrations and platelet aggregation.
As this is a randomised cross-over study, the primary endpoints will be evaluated both after intake of non enteric coated acetylsalicylic acid (Hjertemagnyl®) and enteric coated acetylsalicylic acid (Hjertealbyl®). |
De primære endepunkter vil blive evalueret efter indsamling af alle data. Der udføres ikke interim analyser.
Blod til måling af de primære endepunkter indsamles på dag 7 og dag 8 efter indtag af 7. dosis acetylsalicylsyre, hvor vi udfører serielle målinger af acetylsalicylsyre koncentrationer samt trombocyt aggregation.
Da dette er et randomiseret cross-over studie, bliver de primære endepunkter evalueret både efter indtag af non enterocoated acetylsalicylsyre (Hjertemagnyl®) og enterocoated acetylsalicylsyre (Hjertealbyl®)
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E.5.2 | Secondary end point(s) |
- Maximal salicylic acid concentration. - The area under the concentrationcurves for acetylsalicylic acid and salicylic acid - Time above a certain concentration of acetylsalicylic acid and salicylic acid. - The time for maximal concentrations of acetylsalicylic acid and salicylic acid. - Platelet inhibition at the time of maximal salicylic acid concentration. - Maximal platelet inhibition - The area under the effect curve - Platelet inhibition 24 hours after acetylsalicylic acid intake (through effect) - Time for maximal platelet inhibition. - Platelet count and other platelet-, erytrocyte- and leukocytederived Sysmex® parameters (heamatological parameters)
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- Maksimale salicylat koncentration efter indtag - Arealet under acetylsalicylsyres og salicylats koncentrationskurver - Tid over en given acetylsalicylsyre og salicylat koncentration. - Tidspunktet for maksimale acetylsalicylsyre og salicylat koncentrationer. - Trombocythæmning til tidspunktet for maksimale salicylat koncentration. - Maksimale trombocythæmning - Areal under effektkurven - Trombocythæmning 24 timer efter acetylsalicylsyre indtag (daleffekt) - Tidspunkt for maksimal trombocythæmning. - Trombocyttal og øvrige trombocyt-, erytrocyt- og leukocytderiverede Sysmex® parametre (hæmatologiske parametre)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secondary end points will be evaluated after the collection of all data. No interim analyses will be performed.
Blood for measurement of the secondary endpoints will be collected at day 7 after intake of the 7 th. dose of acetylsalicylic acid, where we will perform serial measurements of acetylsalicylic acid concentrations and platelet aggregation.
As this is a randomised cross-over study, the secondary endpoints will be evaluated both after intake of non enteric coated acetylsalicylic acid (Hjertemagnyl®) and enteric coated acetylsalicylic acid (Hjertealbyl®). |
De sekundære endepunkter vil blive evalueret efter indsamling af alle data. Der udføres ikke interim analyser.
Blod til måling af de sekundære endepunkter indsamles på dag 7 efter indtag af 7. dosis acetylsalicylsyre, hvor vi udfører serielle målinger af acetylsalicylsyre koncentrationer samt trombocyt aggregation.
Da dette er et randomiseret cross-over studie, bliver de sdekundære endpoints evalueret både efter indtag af non enterocoated acetylsalicylsyre (Hjertemagnyl®) og enterocoated acetylsalicylsyre (Hjertealbyl®) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS. |
Sidste forsøgspersons sidste besøg. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |