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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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Primary objective:
Secondary objectives are to investigate the potential food effect on:
The total duration per subject is 8-9 weeks broken down as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group clopidogrel fed - fasting | Experimental | Period 1:
Period 2:
|
|
| Group placebo fed - fasting | Placebo Comparator | Period 1:
Period 2:
|
|
| Group clopidogrel fasting - fed | Experimental | Period 1:
Period 2:
|
|
| group placebo fasting -fed | Placebo Comparator | Period 1:
Period 2:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clopidogrel | Drug | Pharmaceutical form: tablet Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment | Day 5 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum platelet aggregation intensity (MAI) induced by ADP 5µM after loading dose and high fat breakfast | 6 hours and 24 hours after first dosing of each period | |
| Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment |
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Inclusion Criteria:
Healthy male 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 | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22128201 | Result | Hurbin F, Boulenc X, Daskalakis N, Farenc C, Taylor T, Bonneau D, Lacreta F, Cheng S, Sultan E. Clopidogrel pharmacodynamics and pharmacokinetics in the fed and fasted state: a randomized crossover study of healthy men. J Clin Pharmacol. 2012 Oct;52(10):1506-15. doi: 10.1177/0091270011419852. Epub 2011 Nov 29. |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Matching placebo | Drug | Pharmaceutical form: tablet Route of administration: oral |
|
| up to 24 hours postdose on Day 5 for each period |
| Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment | up to 24 hours postdose on Day 5 for each period |
| Paris |
| France |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |