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Food-Effect Pharmacokinetic Study of PL2200

NCT ID: NCT01244100

Last Updated: 2010-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.

Detailed Description

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Conditions

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Healthy

Keywords

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Food-effects PK study in healthy subjects.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PL2200

Group Type EXPERIMENTAL

PL2200 fasted

Intervention Type DRUG

Fasted state

PL2200 fed

Intervention Type DRUG

Fed state

Interventions

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PL2200 fasted

Fasted state

Intervention Type DRUG

PL2200 fed

Fed state

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy normal male and female volunteers between 21 and 65 years of age.

Exclusion Criteria

* Abnormal findings on physical examination or clinical laboratories, or significant medical history.
* Subject with hypersensitivity or contraindications to aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drug (NSAID).
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PLx Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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PLx Pharma Inc.

Principal Investigators

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Upendra K Marathi, PhD

Role: STUDY_DIRECTOR

PLx Pharma Inc.

Locations

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Houston Institute for Clinical Research

Houston, Texas, United States

Site Status

Countries

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United States

References

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Angiolillo DJ, Bhatt DL, Lanza F, Deliargyris EN, Prats J, Fan W, Marathi U. Bioavailability of aspirin in fasted and fed states of a novel pharmaceutical lipid aspirin complex formulation. J Thromb Thrombolysis. 2020 Apr;49(3):337-343. doi: 10.1007/s11239-020-02051-5.

Reference Type DERIVED
PMID: 32080811 (View on PubMed)

Other Identifiers

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PL-ASA-003

Identifier Type: -

Identifier Source: org_study_id