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NCT05055752 · ClinicalTrials.gov registry record · Phase 1
Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.
A Phase 1 study of Bioequivalence, sponsored by PLx Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05055752: Completed Phase 1 study of Bioequivalence, sponsored by PLx Pharma.
NCT05055752 is a Phase 1 study of Bioequivalence that has completed, run by PLx Pharma. The registered enrollment target is 24 participants, below the 64-participant average among 3 other Bioequivalence trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05055752, a Phase 1 study of Bioequivalence, has completed, sponsored by PLx Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial is a randomized, actively-controlled, open-label, 2-way crossover bioequivalence study to determine PK parameters following treatment with test aspirin product (PL-ASA capsules) and reference aspirin product (IR-ASA tablets) administered at a single dose of 325 mg.
Primary Outcome
Bioequivalence using serum determinations of acetylsalicylic acid concentration
Conditions Studied
Interventions
- DRUG Pharmaceutical-lipid aspirin (PL-ASA)
Study Locations (1)
Kansas
- PRA-EDS - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-05-07 |
| Est. Completion | 2020-10-01 |
| Phase | Phase 1 |
What the finished NCT05055752 record still lists
NCT05055752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 64-participant average among 3 other Bioequivalence trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Bioequivalence appearing as the primary indexed condition, and to 1 intervention - of which Pharmaceutical-lipid aspirin (PL-ASA) is the first listed.
NCT05055752 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT05055752 about?
NCT05055752 is a clinical study titled "Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.". This trial is a randomized, actively-controlled, open-label, 2-way crossover bioequivalence study to determine PK parameters following treatment with test aspirin product (PL-ASA capsules) and reference aspirin product (IR-ASA tablets) administered at a single dose of 325 mg.
What is the current status of trial NCT05055752?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-05-07. Estimated completion is 2020-10-01.
What conditions does trial NCT05055752 study?
This clinical trial studies the following conditions: Bioequivalence.
What interventions are being tested in trial NCT05055752?
The interventions under investigation include: Pharmaceutical-lipid aspirin (PL-ASA) (DRUG).
Who is sponsoring clinical trial NCT05055752?
This trial is sponsored by PLx Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05055752 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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