E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Young healthy men (intended indication cardiovascular disease) |
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E.1.1.1 | Medical condition in easily understood language |
Young healthy men (intended indication cardiovascular disease) |
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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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071110 |
E.1.2 | Term | Atherothrombosis prophylaxis |
E.1.2 | System Organ Class | 100000004865 |
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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 |
To compare the bioavailabilty of clopidogrel administered as 75 mg Plavix® tablet to that of 75 mg of clopidogrel in drinkable solution, after single oral administration, in fasting state, to normal healthy subjects |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male healthy subjects, between 18 and 40 years of age.
2. Weight between 60 kg and 90 kg, Body Mass Index between 18 and 28 kg/m2, inclusive (Appendix 1).
3. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
4. Normal vital signs after 10 minutes in supine position:
95 mmHg < systolic blood pressure < 140 mmHg,
50 mmHg < diastolic blood pressure < 90 mmHg,
45 bpm ≤ heart rate ≤ 90 bpm.
5. Normal 12-lead ECG, , PR < 210 ms, QRS < 120 ms, QTcB ≤ 430 ms (incomplete bundle branch block can be accepted).
6. Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator.
7. Having given a written informed consent prior to selection.
8. Subject with normal dietary habits. |
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E.4 | Principal exclusion criteria |
1. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease.
2. Frequent headaches and / or migraine, recurrent nausea and / or vomiting.
3. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
4. Blood donation (including in the frame of a clinical trial) or general anesthesia within 3 months before administration.
5. Presence or history of any allergy or unusual reactions to drugs or anesthetics.
6. Unable to abstain from intensive muscular effort.
7. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
8. Subject in the exclusion period of a previous study.
9. Subject who cannot be contacted in case of emergency.
10. Any medication within one month before the administration, or within 6 times the elimination half-life of that drug.
11. Any drug intake within 3 months before administration which could lead to induction or inhibition of microsomal enzymes (Appendix 5).
12. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day) (Appendix 2).
13. Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day).
14. Smoking more than 5 cigarettes or equivalent / day.
15. Positive HBs antigen or anti HCV antibody, or positive results for HIV tests.
16. Positive results of screening for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetic parameters
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Study duration (D-1 - D24) |
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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 | Yes |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
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) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Relative bioavailability study between 2 pharmaceutical forms of clopidogrel |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 20 |