Bioavailability study with two formulations of Clopidogrel in young healthy men.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2015-001245-89-Outside-EU/EEA
• Date of registration: 13/04/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi-aventis
• Public title: Bioavailability study with two formulations of Clopidogrel in young healthy men.
• Scientific title: Relative bioavailability study between 75 mg tablet and 75 mg solution of Clopidogrel (SR25990C) after single oral administration to young healthy men. Open, crossover, randomized and monocenter study
• Target sample size: 24
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001245-89
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: yes Other trial design description: Relative bioavailability study between 2 pharmaceutical forms of clopidogrel If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

France

Contacts

• Name: Trial Transparency Team
• Affiliation: Sanofi Aventis Recherche & Developpement

• Name: Trial Transparency Team
• Affiliation: Sanofi Aventis Recherche & Developpement

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Young healthy men (intended indication cardiovascular disease)
MedDRA version: 17.1 Level: LLT Classification code 10071110 Term: Atherothrombosis prophylaxis System Organ Class: 100000004865

Intervention(s)

Product Name: Clopidogrel
Product Code: SR25990C
Pharmaceutical Form: Solution for use in drinking water
INN or Proposed INN: CLOPIDOGREL
Current Sponsor code: SR25990C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Product Name: Clopidogrel
Product Code: SR25990C
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOPIDOGREL
Current Sponsor code: SR25990C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: t (0h-48h)

Secondary Objective: Safety of treatment

Main Objective: 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

Primary end point(s): Pharmacokinetic parameters

Secondary Outcome(s)

Secondary end point(s): Safety evaluation

Timepoint(s) of evaluation of this end point: Study duration (D-1 - D24)

Secondary ID(s)

BDR4580

Source(s) of Monetary Support

Sanofi-aventis