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Food-Effect Pharmacokinetic Study of PL2200

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244100
First Posted: November 19, 2010
Last Update Posted: December 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
PLx Pharma
  Purpose
This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.

Condition Intervention Phase
Healthy Drug: PL2200 fasted Drug: PL2200 fed Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)

Further study details as provided by PLx Pharma:

Primary Outcome Measures:
  • Effect of food by ratio of least-squares means (LSM) of the pharmacokinetic (PK) parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state. [ Time Frame: 24 hours ]
  • Effect of food by ratio of least-squares means (LSM) of the PK parameter of AUC0-inf of the primary metabolite, salicylic acid, in the fed state versus the fasted state. [ Time Frame: 24 hours ]
  • Effect of food by ratio of least-squares means (LSM) of the PK parameter of Cmax of the primary metabolite, salicylic acid, in the fed state versus the fasted state. [ Time Frame: 24 hours ]

Estimated Enrollment: 20
Study Start Date: October 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PL2200 Drug: PL2200 fasted
Fasted state
Drug: PL2200 fed
Fed state

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244100


Locations
United States, Texas
Houston Institute for Clinical Research
Houston, Texas, United States, 77074
Sponsors and Collaborators
PLx Pharma
Investigators
Study Director: Upendra K Marathi, PhD PLx Pharma Inc.
  More Information

Responsible Party: Jason Moore, Vice President, PLx Pharma Inc.
ClinicalTrials.gov Identifier: NCT01244100     History of Changes
Other Study ID Numbers: PL-ASA-003
First Submitted: October 25, 2010
First Posted: November 19, 2010
Last Update Posted: December 13, 2010
Last Verified: December 2010

Keywords provided by PLx Pharma:
Food-effects PK study in healthy subjects.

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics