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NCT04328883 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin
A Phase 1 study, sponsored by Inova Health Care Services.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT04328883 is a Phase 1 study that has completed, run by Inova Health Care Services. The registered enrollment target is 19 participants.
The verdict
NCT04328883, a Phase 1 study, has completed, sponsored by Inova Health Care Services.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
ASA inhalation powder is an inhaled nonsteroidal anti-inflammatory drug-device combination that has been developed to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI), an FDA approved indication for oral formulations of aspirin. The primary goal of study OTP-P0-926 is to collect pharmacokinetic (PK)and pharmacodynamics (PD) pilot data to determine onset and extent of aspirin response after administration of varying doses of inhaled ASA (50-100mg) and 162 mg Non-Enteric-Coated Chewable ASA. PD will be assessed using standard methods to measure platelet inhibition by aspirin including platelet aggregation, serum thromboxane,and urinary thromboxane. Furthermore, the pharmacokinetics (PK) of ASA will be determined and compared to PD measurements. Results of this pilot study will guide dosing in a subsequent larger Phase II study.
Interventions
- DRUG Aspirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-07-16 |
| Est. Completion | 2019-10-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04328883
The ClinicalTrials.gov registry entry for NCT04328883 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inova Health Care Services, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aspirin is the first listed.
NCT04328883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04328883 about?
NCT04328883 is a clinical study titled "Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin". ASA inhalation powder is an inhaled nonsteroidal anti-inflammatory drug-device combination that has been developed to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI), an FDA approved indication for oral formulations of aspirin. The primary goal of s...
What is the current status of trial NCT04328883?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-07-16. Estimated completion is 2019-10-10.
What interventions are being tested in trial NCT04328883?
The interventions under investigation include: Aspirin (DRUG).
Who is sponsoring clinical trial NCT04328883?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
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