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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008450-22 | EudraCT Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The objectives of the study are to:
The total study duration per subject is 4 - 6 weeks broken down as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence clopidogrel 75 / 75 / 300 mg | Experimental | Period 1: clopidogrel 75 mg single dose Period 2: clopidogrel 75 mg single dose Period 3: clopidogrel 300 mg single dose Each intake is at around 8:00 AM under fasted conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Pharmaceutical form : tablet Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC)) | Up to 48 hours postdose for each period | |
| Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC) | Up to 48 hours postdose for each period |
| Measure | Description | Time Frame |
|---|---|---|
| Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z)) | Up to 48 hours postdose for each period | |
| Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z) | Up to 48 hours postdose for each period |
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Inclusion Criteria:
Healthy subjects:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| International Clinical Development Study Director | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Paris | France |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |