Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
NCT Number: NCT01129427
Primary objective:
* Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with pantoprazole 80 mg/day compared to given alone in healthy male subjects * Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel is given either alone or concomitantly with pantoprazole
Secondary Objective:
* Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either alone or concomitantly with pantoprazole
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Notify Me18 year–65 year
Male
Interventional
Phase 1
Bridgewater, New Jersey, 08807, United States
The total study duration per subjects is 8 - 9 weeks broken down as follows:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy male subject:
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form: tablet
Route of administration: oral
Other names: SR25990
Pharmaceutical form: matching tablet
Route of administration: oral
Pharmaceutical form: delayed-release tablet
Route of administration: oral
Other names: PROTONIX
Time frame: Day 5 of each period
Time frame: Up to 24 hours postdose on Day 5 of each period
Time frame: Day 5 of each period
Time frame: Day 5 of each period
Time frame: Up to 24 hours postdose on Day 5 for each period
Sanofi
Industry
A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given Concomitantly With Pantoprazole 80 mg/Day in Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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