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This study aims to evaluate the influence of tegoprazan or RAPA113 on the pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and clopidogrel in healthy male volunteers.
Evaluation Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel 75 mg | Active Comparator | Oral administration of clopidogrel 75 mg tablet once daily for 7 days |
|
| Clopidogrel 75 mg + Tegoprazan 50 mg | Experimental | Oral administration of clopidogrel 75 mg tablet and Tegoprazan 50mg tablet once daily for 7 days |
|
| Clopidogrel 75 mg + RAPA113 | Experimental | Oral administration of clopidogrel 75 mg tablet and RAPA113 tablet once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel 75mg | Drug | Clopidogrel 75 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in P2Y12 Reaction Unit (PRU) from baseline | Pharmacodynamics blood sampling to measure PRU using VerifyNow® system | Pre-dose(0h) on days 1, 3, 5, 7 and 8 in each period |
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Inclusion Criteria:
Exclusion Criteria:
Has a history of or currently has clinically significant liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood, tumor, cardiovascular system or psychiatric disease
Has a history of gastrointestinal diseases (such as Crohn's disease, ulcer, etc.) or surgery (except for simple appendectomy or hernia) that can affect the absorption of drugs
Has a genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Has a clinically significant history of hemorrhage (e.g. Gastric ulcers, intracranial bleeding, haemophilia, gastrointestinal bleeding, urinary tract bleeding, vitreous hemorrhage, etc.)
P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range by 10% at screening
Considered ineligible to participate in the study based on screening test(by asking condition, vital sign, 12-lead ECG, physical exam, laboratory test etc.) results :
Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10%
AST (GOT), and ALT (GPT) levels greater than 1.25x of the upper limit of normal range
Blood total bilirubin levels greater than 1.5x of the upper limit of normal range
Hemoglobin levels less than 12.0 g/dL
eGFR (estimated Glomerular Filtration Rate) using MDRD (Modification of Diet in Renal Disaster) < 60 mL/min/1.73 m2
: eGFR (estimated glomerular filtration rate) (mL/min/1.73m2) = 175 x [serum creatinine (mg/dL)]-1.154 x [age]-0.203
positive as a result of serum examination (B-type hepatitis test, hepatitis C test, human immunodeficiency virus test, syphilis test)
Systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 50 mmHg or > 100 mmHg, or pulse rate < 45 beats/minute or > 100 beats/minute when vital signs are measured in sitting position after resting for at least 5 minutes during screening
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| Name | Affiliation | Role |
|---|---|---|
| Min Soo Park | Severance Hospital, Dept of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| C000631239 | tegoprazan |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Tegoprazan 50 mg | Drug | Tegoprazan 50 mg tablet |
|
|
| RAPA113 | Drug | RAPA113 tablet |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |