Bioequivalence
Conditions
Brief summary
Prospective, Randomized, Crossover, Bioequivalence study
Detailed 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.
Interventions
DRUGAspirin
Aspirin - lipid complex
Sponsors
PLx Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
32 subjects to be randomized to treatment with either immediate release aspirin or PL-ASA at one of two doses (325 mg or 650 mg) administered orally. After completion of the first treatment and a minimum of a two week washout period(14-17 days) subjects are to cross over and receive treatment with the alternative compound at the same dose level.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T | twenty four hours | Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-T of the metabolite salicylic acid |
| Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-∞ | 24 hours | Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-∞ of the metabolite salicylic acid |
| Bioequivalence of PL-ASA and Immediate Release Aspirin CMAX | 24 hours | Assess for bioequivalence at 325 mg and 650 mg dose levels CMAX of the metabolite salicylic acid |
| Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX | 24 hours | Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the metabolite salicylic acid |
| Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-24 | 24 hours | Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-24 of the percent inhibition of serum Thromboxane B2 |
| Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX STB2 | 24 hours | Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the percent inhibition of serum Thromboxane B2 |
Outcome results
None listed