Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01129063
First received: May 21, 2010
Last updated: August 27, 2010
Last verified: August 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The objectives of the study are to:
- Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
- Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Clopidogrel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC)) [ Time Frame: Up to 48 hours postdose for each period ] [ Designated as safety issue: No ]
- Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC) [ Time Frame: Up to 48 hours postdose for each period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z)) [ Time Frame: Up to 48 hours postdose for each period ] [ Designated as safety issue: No ]
- Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z) [ Time Frame: Up to 48 hours postdose for each period ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | March 2009 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sequence clopidogrel 75 / 75 / 300 mg
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. |
Drug: Clopidogrel
Pharmaceutical form : tablet Route of administration: oral Other Name: SR25990
|
Detailed Description:
The total study duration per subject is 4 - 6 weeks broken down as follows:
- Screening: 2 to 21 days before the first dosing
- Period 1, 2 and 3: 4 days including 1 treatment day each
- Washout between periods: at least 7 days between 2 administrations
- End of study: 7 to 10 days after the last dosing
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Healthy subjects:
- as determined by medical history and complete physical examination including vital signs and clinical laboratory tests
- with a body weight between 50kg and 95 kg if male, between 40.0 kg and 85.0 kg if female and a Body Mass Index (BMI) between 18 and 28 kg/m2
Exclusion Criteria:
- Evidence of inherited disorder of coagulation/hemostasis functions
- Smoking more than 5 cigarettes or equivalent per day
- Abnormal hemostasis screen
- Any contraindication to clopidogrel
- Unability to abstain from intake of any drug affecting haemostasis throughout the whole study duration.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations More Information
No publications provided
| Responsible Party: | International Clinical Development Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT01129063 History of Changes |
| Other Study ID Numbers: | PKM11086, 2008-008450-22 |
| Study First Received: | May 21, 2010 |
| Last Updated: | August 27, 2010 |
| Health Authority: | United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists |
Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013