Compatibility of clopidogrel prepared for administration through nasogastric tube with enteral nutrition (CPU-003)

Phase 1

• Conditions: healthy volunteers; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2017-003411-19-CZ
• Lead Sponsor: Fakultní nemocnice u sv. Anny v Brne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-09
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Volunteers of both sex
Age 18 - 45 years
Weight 50 - 100 kg and BMI 18,5 - 30,0 kg/m2
Non-smokers
Without chronic medication (except of hormonal contraception), drugs influencing platelets or coagulation allowed till 14 days before the administration of the study medication; acetaminophen, metamizole, pitofenone and antihistamines are allowed 48 hours before and after administration of the study medication
Physical examination without clinically significant deviation
Blood pressure and ECG without clinically significant deviations
Laboratory results in reference ranges or clinically insignificant deviations
Read Informations for volunteers
Signed Informed consent
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any serious illness even in medical history
Any cardiovascular illnes even in medical history
Hemorrhagic diathesis even in medical history
Liver or renal dysfunction
Hypersensitivity to active substance or excipients
Milk intolerance
Pregnancy or lactation
Alcohol or psychotropic agent abuse
Active bleeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified