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The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid metabolite between generic and reference clopidogrel products in Thai healthy volunteers
Platelet aggregation (ex vivo) were measured by using Whole blood impedence aggregometry (Chrono-log®) and VerifyNow® P2Y12 assay. Plasma concentration of clopidogrel carboxylic acid metabolite were measured by High performance liquid chromatography (HPLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generic clopidogrel product | Experimental | Apolets® 75 mg tablet |
|
| Original clopidogrel product | Active Comparator | Plavix® 75mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic clopidogrel product Apolets® | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State) | Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24) | Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 | |
| Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wichittra Tassaneeyakul, Ph.D. | Khon Kaen University | Principal Investigator |
| Somsak Tiamkao, MD | Khon Kaen University | Principal Investigator |
| Sirimas Kanjanawart, Ph.D. | Khon Kaen University | Principal Investigator |
| Kutcharin Phunikhom, MD | Khon Kaen University | Principal Investigator |
| Nontaya Nakkam, B.Pharm | Khon Kaen University | Principal Investigator |
| Thanawat Kaewkamsorn, M.Sc. | Khon Kaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Khon Kaen University | Khonkaen | Changwat Khon Kaen | 40000 | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Generic Clopidogrel Product | Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days -Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
| FG001 | Original Clopidogrel Product | Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days -Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
| |||||||||||||
| Wash Out Period (14 Days) |
| |||||||||||||
| Second Intervention (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | First intervention: Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 Wash out period: 14 days Second intervention: Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State) | Posted | Mean | Standard Deviation | percent inhibition*hour | Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Generic Clopidogrel Product | Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days -Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Nontaya Nakkam | Khon Kaen University | 66862642540 | nonna_na@hotmail.com |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| Original clopidogrel product Plavix® | Drug |
|
|
|
| Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
| Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax) | Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
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| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24) | Not Posted | Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
| Secondary | Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax) | Not Posted | Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
| Secondary | Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax) | Not Posted | Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Original Clopidogrel Product | Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days -Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 | 0 | 31 | 0 | 31 |
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |