Prospective, Randomized, Crossover, Bioequivalence study
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Aspirin - lipid complex
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
Time frame: twenty four hours
Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-∞
Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-∞ of the metabolite salicylic acid
Time frame: 24 hours
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
Time frame: 24 hours
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
Time frame: 24 hours
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
Time frame: 24 hours
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
Time frame: 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.