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Effect of polymorphic CYP2C19 genotype on the pharmacokinetics and pharmacodynamics of clopidogrel in healthy subjects

Effect of polymorphic CYP2C19 genotype on the pharmacokinetics and pharmacodynamics of clopidogrel in healthy subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39669611
Enrollment
24
Registered
2007-09-17
Start date
2007-03-01
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

Cardiovascular diseases Circulatory System Cardiovascular diseases

Interventions

After a loading dose of clopidogrel (300 mg
oral), patients will take a standard dose of clopidogrel 75 mg once a day for 6 days. The following will be carried out: 1. Assessment of PK of clopidogrel and its met

Sponsors

Korea University (South Korea)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Healthy male subjects aged between 19 to 55 2. Wish to participate in the study 3. Informed consent for the trial

Exclusion criteria

Exclusion criteria: 1. A history of or currently active clinically significant cardiac (including clinically significant abnormalities on Electrocardiogram [ECG] according to Principal Investigator [PI]), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease 2. Heavy smoker and alcohol consumer 3. Use of anticoagulants or medication within the last 1 month

Design outcomes

Primary

MeasureTime frame
Genetic association with biological effect of clopidogrel.

Secondary

MeasureTime frame
PK/PD relationship.

Countries

Korea, South

Outcome results

None listed

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