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This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PL2200 Aspirin Capsules | Experimental | PL2200 Aspirin Capsules |
|
| Enteric-coated aspirin caplets | Active Comparator | Enteric-coated aspirin caplets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PL2200 Aspirin Capsules | Drug | 325 mg aspirin; once per day for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 99% Inhibition of Serum Thromboxane | Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy. | 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | United States | ||
| PRA Clinical Pharmacology Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | PL2200 Aspirin First, Then Enteric Coated (EC) Aspirin | First Intervention Period: PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days (after 2-week washout period) Second Intervention Period: EC aspirin: 325 mg aspirin; once per day for 10 days |
| FG001 | Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin | First Intervention Period: EC aspirin: 325 mg aspirin; once per day for 10 days (after 2-week washout period) Second Intervention Period: PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
All patients that received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All patients that received at least 1 dose of study drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to 99% Inhibition of Serum Thromboxane | Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy. | Pharmacodynamic (PD) Evaluable Population - patients in the intent-to-treat population who received a full treatment regimen for each of 2 study drugs, had all scheduled PD blood draws, and had no other major protocol violations. | Posted | Mean | Standard Deviation | hours | 11 days |
|
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Intent-to-Treat Population: patients that received at least 1 dose of study drug.
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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 | PL2200 Aspirin Capsules | PL2200 Aspirin Capsules PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Zimmerman, President & CEO | PLx Pharma | 713-842-1249 | 205 | ron.zimmerman@plxpharma.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Enteric-coated aspirin caplets |
| Drug |
325 mg aspirin; once per day for 10 days |
|
| Lenexa |
| Kansas |
| 66219 |
| United States |
| Medpace Clinical Pharmacology | Cincinnati | Ohio | 45227 | United States |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Enteric-coated Aspirin Caplets | Enteric-coated aspirin caplets Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days |
|
|
| 0 |
| 57 |
| 2 |
| 57 |
| EG001 | Enteric-coated Aspirin Caplets | Enteric-coated aspirin caplets Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days | 0 | 56 | 2 | 56 |
Standard confidentiality agreement
| D004700 | Endocrine System Diseases |