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Completed

NCT Number: NCT01244100

Food-Effect Pharmacokinetic Study of PL2200

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

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Houston Institute for Clinical Research

Houston, Texas, 77074, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PL2200 fasted

Drug

Fasted state

PL2200 fed

Drug

Fed state

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

PLx Pharma

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Nov 19, 2010
Registry last updated
Dec 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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