A Comparative Single-Dose Bioequivalence Study of Two Enteric Coated Aspirin Brands Among Healthy Volunteers

Journal of Applied Research

Volumn 3, Issue 3, 2003, Pages 242-248

  Zeitoun, Abeer A ^a   Dib, Jean G ^a   Mroueh, Mohammad ^a  

^a LEBANESE AMERICAN UNIVERSITY   (Lebanon)

Author keywords

Acetylsalicylic acid (ASA); Bioavailability; Bioequivalence; HPLC

Indexed keywords

ACETYLSALICYLIC ACID; ASPICOT; ASPIRIN PROTECT;

AREA UNDER THE CURVE; ARTICLE; BIOAVAILABILITY; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG SOLUBILITY; DUODENUM ULCER; DYSPEPSIA; ENTERIC COATED TABLET; FEMALE; GASTROINTESTINAL HEMORRHAGE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; MALE; MAXIMUM ALLOWABLE CONCENTRATION; NORMAL HUMAN; OCCULT BLOOD; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH EROSION; TABLET FORMULATION; VENOUS BLOOD;

EID: 0142157032     PISSN: 1537064X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (18)

1. Awtry AE, Loscalzo J: Aspirin. Circulation 101:1206-1218, 2000.
2. Abdel-Rhaman MS, Reddi AS, Curro FA, et al: Bioavailability of aspirin and salicylamide flowing oral co-administration in human volunteers. Canadian Journal of Physiology and Pharmacology 69:1436-1442, 1991.
3. Hawaky CJ: COX-2 inhibitors. Lancet 353:307-314, 1999.
4. Fitzgerald GA: Mechanisms of platelet activation: thromboxane A2 as an amplifying signal for other agonists. Am J Cardiol 68:11B-15B, 1991.
5. Clissold SP: Aspirin and related derivatives of salicylic acid. Drugs 32(suppl 4):8-26, 1986.
6. Patrono C, Collar B, Dalen J, et al: Platelet-active drugs: the relationship among dose, effectiveness, and side effects. Chest 114:470S-488S, 1998.
7. Lopez-Farre A, Caramelo C, Esteban A, et al: Effect of aspirin on platelet-neutrophil interactions: role of nitric oxide and endothelin-1. Circulation 91:2080-2088, 1995.
8. Hussein S, Andrew NP, Mulcahy D, et al: Aspirin improves endothelial dysfunction in atherosclerosis. Circulation 97:716-720, 1998.
9. Ridker PM, Cushman M, Stamper MJ, et al: Inflammation, aspirin, and the risks of cardiovascular disease in apparently healthy men. N Engl J Med 336:973-979, 1997.
10. Jimenz AH, Stubbs ME, Tofler GH, et al: Rapidity and duration of platelet suppression by enteric coated aspirin in young healthy volunteers men. Am J Cardiol 69:258-262, 1992.
11. Weksler BB, Pett SB, Alonso D, et al: Differential inhibition by aspirin of vascular and platelet prostaglandin synthesis in atherosclerotic patients. N Engl J Med 308:800-805, 1983.
12. Tohgi H, Konno S, Tamura K, et al: Effects of low to high doses of aspirin on platelet aggregability and metabolites of thromboxane A2 and prostacyclin. Stroke. 23:1400-1403, 1992.
13. Kees F, Jehnich D, Grobecker H: Simultaneous determination of acetylsalicylic acid and salicylic acid in human plasma by high-performance liquid chromatography. Journal of Chromatography B 677:172-177, 1996.
14. Chow CS, Liu JP: Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Dekker; 1992:1-2.
15. US Food and Drug Administration (FDA): Guidance: statistical procedure for bioequivalence studies using standard 2-treatment crossover design. Statement under 21 CRF 10.9. Rockville, MD: US Department of Health and Human Services; 1992.
16. Committee for Proprietary Medicinal Products (CPMP) Working Party on the Efficacy of Medicinal Products: Note for guidance: investigation of bioavailability and bioequivalence. Brussels; 1991.
17. Kwong TC: Salicylate measurement: Clinical Usefulness and Methodology, Crit Rev Clin Lab Sci 25:137-159, 1987.
18. Kwong I, Adams N, Young N: Rapid determination of salicylate in serum on acentrifugal analyzer. Clin Biochem 17:170-172, 1984.