Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

Bioequivalence Clinical Trial

Official title:

Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008979
• Other study ID #: 74,290
• Status: Completed
• Phase: Phase 1
• Start date: February 11, 2008
• Est. completion date: June 10, 2008

Study information

• Verified date: July 2019
• Source: PLx Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, Randomized, Crossover, Bioequivalence study

Description:

Active-control crossover study randomizing 32 healthy volunteers to receive one of two dose levels, 325 mg or 650 mg, of either PL-ASA or immediate release aspirin within a two week washout period between treatments. The primary objectives are to assess PK and PD bioequivalence and safety over a twenty four hour period for PL-ASA and immediate release aspirin at 325 mg and 650 mg dose strengths.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 10, 2008
• Est. primary completion date: June 10, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• If female and of childbearing potential, subject has a negative pregnancy test and is not nursing.

• If female and of childbearing potential, subject is using adequate birth control for the duration of the study.

• Subject is able to understand and comply with study procedures.

• Subject is a non-smoker.

• Subject consumes no more than 1 alcoholic drink per day.

• Subject agrees to refrain from alcohol consumption for 48 hours prior to each drug administration and 48 hours after each drug administration.

• Subject is able and willing to provide written informed consent prior to any study procedures being performed.

Exclusion Criteria:

• Subject has abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator.

• Subject has taken any prescription medications other than hormone replacement therapy or thyroid replacement hormones within 3 days prior to drug administration.

• Subject has taken any of the following medications within 2 weeks prior to study entry:

• NSAIDs or other medications for pain, including aspirin or aspirin containing products and acetaminophen (see Appendix B of protocol in Appendix 16.1.1)

• Proton pump inhibitors, including Prilosec®, Prevacid®, Aciphex®, Protonix®, or Nexium®

• H-2 blockers, including Tagamet®, Zantac®, Axid®, or Pepcid®

• Any antiplatelet agent, including Plavix®, Ticlid®, Pletal®, ReoPro®, Integrilin®, Aggrastat®, or Persantine®

• Any anti-coagulant, including Coumadin®, Acenocoumarol, Phenprocoumon, Phenindione, Heparin, Exanta®, Argatroban, Lepirudin, Hirudin or Bivalirudin

• Subject has used an investigational agent within the past 30 days.

• Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.

• Subject has sensitivity to lecithin.

• Subject has a history of gastrointestinal problems including ulcers, frequent indigestion, or heartburn.

• Subject has a history of stroke, myocardial infarction, or congestive heart failure.

• Subject has a history of asthma, other bronchospastic activity, nasal polyps, or angioedema other than resolved childhood asthma.

• Subject has a history of kidney or liver disease.

• Subject has a history of thrombocytopenia, neutropenia, or bleeding disorder.

• Subject has a history of coronary arterial bypass.

• Subject has a history of non-trauma related hemorrhage.

• Subject has a history of chronic hypertension.

• Subject is currently enrolled in another investigational trial.

• Subject's platelets are unresponsive to arachidonic acid

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• Aspirin
Aspirin - lipid complex

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PLx Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T	Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-T of the metabolite salicylic acid	twenty four hours
Primary	Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-8	Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-8 of the metabolite salicylic acid	24 hours
Primary	Bioequivalence of PL-ASA and Immediate Release Aspirin CMAX	Assess for bioequivalence at 325 mg and 650 mg dose levels CMAX of the metabolite salicylic acid	24 hours
Primary	Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX	Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the metabolite salicylic acid	24 hours
Primary	Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-24	Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-24 of the percent inhibition of serum Thromboxane B2	24 hours
Primary	Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX STB2	Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the percent inhibition of serum Thromboxane B2	24 hours