Comparative bioavailability of two oral suspensions of naproxen sodium

Arzneimittel-Forschung/Drug Research

Volumn 56, Issue 8, 2006, Pages 589-592

  Carrasco Portugal, Miriam Del Carmen ^a,b   Herrera, Jorge E ^b   Reyes García, Gerardo ^b   Medina Santillán, Roberto ^b   Flores Murrieta, Francisco Javier ^a,b,c  

^a SECRETARÍA DE SALUD   (Mexico)

^b INSTITUTO POLITÉCNICO NACIONAL   (Mexico)

^c HOSPITAL GENERAL DE MÉXICO   (Mexico)

Author keywords

Anti inflammatories; CAS 26159 34 2; Naproxen sodium, bioavailability, bioequivalence, Mexican volunteers, suspensions; Pactens

Indexed keywords

NAPROXEN;

AREA UNDER THE CURVE; ARTICLE; BIOAVAILABILITY; BIOEQUIVALENCE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG FORMULATION; HUMAN; RANDOMIZED CONTROLLED TRIAL;

EID: 33748512093     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296756     Document Type: Article

References (17)

1. Segre, E. J., Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions. J. Reprod. Med. 25 (Suppl.), 222 (1980)
2. Todd, P. A., Clissold, S. P., Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states. Drugs 40, 91 (1990)
3. Bansal, V., Dex, T., Proskin, H. et al., A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis. J. Clin. Pharmacol. 41, 127 (2001)
4. Davies, N. M., Anderson, K. E., Clinical pharmacokinetics of naproxen. Clin. Pharmacokinet. 32, 268 (1997)
5. Niazi, S. K., Alam, S. M., Ahmad, S. I., Partial-area method in bioequivalence assessment: naproxen. Biopharm. Drug Dispos. 18, 103 (1997)
6. Gotzsche, P. C., Marinelli, K., Gylding-Sabroe, J. P. et al., Bioavailability of naproxen tablets and suppositories in steady state. Scand. J. Rheumatol. 50, 1 (1983)
7. Charles, B. G., Mogg, G. A., Comparative in vitro and in vivo bioavailability of naproxen from tablet and caplet formulations. Biopharm. Drug Dispos. 15, 121 (1994)
8. Zhou, D., Zhang, Q., Lu, W. et al., Single- and multiple-dose pharmacokinetic comparison of a sustained-release tablet and conventional tablets of naproxen in healthy volunteers. J. Clin. Pharmacol. 38, 625 (1998)
9. Gamst, O. N., Vesje, A. K., Aarbakke, J., Bioavailability of naproxen sodium suppositories. Int. J. Clin. Pharmacol. Ther. Toxicol. 22, 99 (1984)
10. Wells, T. G., Mortensen, M. E., Dietrich, A. et al., Comparison of the pharmacokinetics of naproxen tablets and suspension in children. J. Clin. Pharmacol. 34, 30 (1994)
11. Norma Oficial Mexicana NOM-177-SSA1-1998. Diario Oficial de la Federación. Tomo DXLVIII No. 4. Mayo 7 de 1999, pp. 44-67 (1999)
12. Rowland, M., Tozer, T. N., Clinical pharmacokinetics. Concepts and applications. 2nd ed., Lea & Febiger, Philadelphia-London (1989)
13. Schuirmann, D. J., A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15, 657 (1987)
14. Pabst, G., Jaeger, H., Review of methods and criteria for the evaluation of bioequivalence studies. Eur. J. Clin. Pharmacol. 39, 5 (1990)
15. Steinijans, V. W., Hauschke, D., Jonkman, J. H. G., Controversies in bioequivalence studies. Clin. Pharmacokinet. 22, 247 (1992)
16. Stolley, P. D., Strom, B. L., Sample size calculations for clinical pharmacology studies. Clin. Pharmacol. Ther. 39, 489 (1986)
17. Zhang, P., A simple formula for sample size calculation in equivalence studies. J. Biopharm. Stat. 13, 529 (2003)