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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003411-19-CZ

Enrollment

Registered

2017-11-09

Start date

2017-11-09

Completion date

Unknown

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

Trade Name: Trombex Pharmaceutical Form: Film-coated tablet Trade Name: Trombex Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the compatibility of crushed Trombex (clopidogrel) with enteral nutrition administered to healthy volunteers. ;Secondary Objective: not applicable;Primary end point(s): drug concentration of clopidogrel in blood platelet aggregation measured by ADPtest ;Timepoint(s) of evaluation of this end point: T-1 = 1 hour before drug administration T0,5 = 30 min after drug administration T1 = 1 hour after drug administration T2 = 2 hours after drug administration T4 = 4 hours after drug administration T8 = 8 hours after drug administration T12 = 12 hours after drug administration	—

Measure

Time frame

Main Objective: To determine the compatibility of crushed Trombex (clopidogrel) with enteral nutrition administered to healthy volunteers. ;Secondary Objective: not applicable;Primary end point(s): drug concentration of clopidogrel in blood platelet aggregation measured by ADPtest ;Timepoint(s) of evaluation of this end point: T-1 = 1 hour before drug administration T0,5 = 30 min after drug administration T1 = 1 hour after drug administration T2 = 2 hours after drug administration T4 = 4 hours after drug administration T8 = 8 hours after drug administration T12 = 12 hours after drug administration

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Czech Republic

Contacts

Public ContactClinical-pharmacological unit

Fakultní nemocnice u sv. Anny v Brne

pavel.suk@fnusa.cz

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026