E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteers |
zdraví dobrovolníci |
|
E.1.1.1 | Medical condition in easily understood language |
healthy volunteers |
zdraví dobrovolníci |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
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 |
To determine the compatibility of crushed Trombex (clopidogrel) with enteral nutrition administered to healthy volunteers. |
Zjistit kompatibilitu rozdrceného léku Trombex (klopidogrel) s enterální výživou na zdravých dobrovolnících. |
|
E.2.2 | Secondary objectives of the trial |
not applicable |
neaplikovatelné |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Volunteers of both sex Age 18 - 45 years Weight 50 - 100 kg and BMI 18,5 - 30,0 kg/m2 Non-smokers Without chronic medication (except of hormonal contraception), drugs influencing platelets or coagulation allowed till 14 days before the administration of the study medication; acetaminophen, metamizole, pitofenone and antihistamines are allowed 48 hours before and after administration of the study medication Physical examination without clinically significant deviation Blood pressure and ECG without clinically significant deviations Laboratory results in reference ranges or clinically insignificant deviations Read Informations for volunteers Signed Informed consent |
Zdraví dobrovolníci obou pohlaví Věk 18–45 let Hmotnost 50–100 kg a BMI 18,5 – 30,0 kg/m2 Nekuřák Bez chronické medikace (kromě antikoncepce); léky ovlivňující trombocyty nebo koagulaci povoleny do 14 dnů před studií; paracetamol, metamizol, pitofenon a antihistaminika 48 hodin před o po podání studijní medikace Klinické vyšetření bez klinicky významných odchylek Krevní tlak a EKG bez klinicky významných odchylek Laboratorní vyšetření v normálním rozmezí nebo klinicky nevýznamné odchylky Přečteny informace pro dobrovolníky Podepsán informovaný souhlas
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E.4 | Principal exclusion criteria |
Any serious illness even in medical history Any cardiovascular illnes even in medical history Hemorrhagic diathesis even in medical history Liver or renal dysfunction Hypersensitivity to active substance or excipients Milk intolerance Pregnancy or lactation Alcohol or psychotropic agent abuse Active bleeding
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Jakékoliv závažné onemocnění i v anamnéze Jakékoliv kardiovaskulární onemocnění i v anamnéze Hemoragická diatéza i v anamnéze Jaterní nebo renální dysfunkce i v anamnéze Hypersenzitivita na léčivou látku nebo kteroukoliv pomocnou látku Intolerance mléka Těhotenství nebo kojení Abusus/závislost na alkoholu a/nebo psychotropních látkách Aktivní krvácení
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E.5 End points |
E.5.1 | Primary end point(s) |
drug concentration of clopidogrel in blood platelet aggregation measured by ADPtest |
koncentrace klopidogrelu v krvi agregace trombocytů měřená pomocí ADPtestu |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
T-1 = 1 hour before drug administration T0,5 = 30 min after drug administration T1 = 1 hour after drug administration T2 = 2 hours after drug administration T4 = 4 hours after drug administration T8 = 8 hours after drug administration T12 = 12 hours after drug administration |
T-1 = 1 hodina před podáním léku T0,5 = 30 min po podání léku T1 = 1 hodina po podání léku T2 = 2 hodiny po podání léku T4 = 4 hodiny po podání léku T8 = 8 hodin po podání léku T12 = 12 hodin po podání léku |
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E.5.2 | Secondary end point(s) |
not applicable |
neplikovatelné |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
neplikovatelné |
|
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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
stejný lék podaný s vodou (zkoumaný lék podán s enterální výživou) |
same drug given with water (study drug given with enteral nutrition) |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | Yes |
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
|
last subject, last visit (phone call) |
poslední subjekt, poslední navštěva (telefonní kontakt) |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |