Food-Effect Pharmacokinetic Study of PL2200

This study has been completed.
Sponsor:
Information provided by:
PLx Pharma
ClinicalTrials.gov Identifier:
NCT01244100
First received: October 25, 2010
Last updated: December 10, 2010
Last verified: December 2010

October 25, 2010
December 10, 2010
October 2010
December 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Effect of food by ratio of least-squares means (LSM) of the PK parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01244100 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Food-Effect Pharmacokinetic Study of PL2200
Not Provided

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Healthy
  • Drug: PL2200 fasted
    Fasted state
  • Drug: PL2200 fed
    Fed state
Experimental: PL2200
Interventions:
  • Drug: PL2200 fasted
  • Drug: PL2200 fed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
December 2010   (final data collection date for primary outcome measure)

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).
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01244100
PL-ASA-003
Not Provided
Jason Moore, Vice President, PLx Pharma Inc.
PLx Pharma
Not Provided
Study Director: Upendra K Marathi, PhD PLx Pharma Inc.
PLx Pharma
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP