Bioavailability and bioequivalence of two oral formulations of alendronate sodium 70 mg: An open-label, randomized, two-period crossover comparison in healthy Korean adult male volunteers

Clinical Therapeutics

Volumn 31, Issue 5, 2009, Pages 1037-1045

  Rhim, Si Youn ^a   Park, Jin Hee ^a,b   Park, Yoo Sin ^a,b   Lee, Min Ho ^b   Kim, Dong Sun ^b   Shaw, Leslie M ^c   Yang, Seok Chul ^d   Kang, Ju Seop ^a,b  

^a Asan Institute for Life Sciences   (South Korea)

^b Hanyang University   (South Korea)

^c HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^d Seoul National University   (South Korea)

Author keywords

alendronate sodium; bioequivalence test; HPLC FLD method; pharmacokinetics

Indexed keywords

ALENDRONIC ACID; PAMIDRONIC ACID;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG FORMULATION; DRUG TOLERABILITY; HALF LIFE TIME; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SOUTH KOREA; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, ORAL; ADULT; ALENDRONATE; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; BONE DENSITY CONSERVATION AGENTS; CHROMATOGRAPHY, LIQUID; CROSS-OVER STUDIES; DRUG ADMINISTRATION SCHEDULE; HUMANS; KOREA; MALE; REFERENCE VALUES; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 66949179352     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.05.001     Document Type: Article

References (16)

1. US Dept of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products (2003), Division of Bioequivalence, Office of Generic Drugs, Rockville, Md. http://www.fda.gov/cder/guidance/5356fnl.pdf Accessed February 12, 2008.
2. Kimmel D.B. Mechanism of action, pharmacokinetic and pharmacodynamic profile, and clinical applications of nitrogen-containing bisphosphonates. J Dent Res 86 (2007) 1022-1033
3. Lin J.H. Bisphosphonates: A review of their pharmacokinetic properties. Bone 18 (1996) 75-85
4. Sparidans R.W., and Den Hartigh J. Chromatographic analysis of bisphosphonates. J Pharm Sci 21 (1999) 1-10
5. Zhu L.S., Lapko V.N., Lee J.W., et al. A general approach for the quantitative analysis of bisphosphonates in human serum and urine by high-performance liquid chromatography/ tandem mass spectrometry. Rapid Commun Mass Spectrom 20 (2006) 3421-3426
6. Tarcomnicu I., Silvestro L., Savu S.R., et al. Development and application of a high-performance liquid chromatography-mass spectrometry method to determine alendronate in human urine. J Chromatogr A 1160 (2007) 21-33
7. Apostolou C., Dotsikas Y., Kousoulos C., et al. Application of a semi-automated 96-well format solid-phase extraction, column-switching, fluorescence detection protocol for the determination of alendronate in human urine samples obtained from a bioequivalence study. J Pharmaceut Biomed Anal 43 (2007) 1151-1155
8. Porras A.G., Holland S.D., and Gertz B.J. Pharmacokinetics of alendronate. Clin Pharmacokinet 36 (1999) 315-328
9. World Medical Association Declaration of Helsinki. Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects (1989), WMA, Ferney-Voltaire, France. http://www.wma.net Accessed January 2, 2008
10. The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit (EMEA). ICH Topic E6: Guideline for Good Clinical Practice. http://efec.net/doc/pdf/lois/BPC-ICHE6.pdf Accessed January 2, 2008.
11. Yun M.H., and Kwon K.I. High-performance liquid chromatog-raphy method for determining alendronate sodium in human plasma by detecting fluorescence: Application to a pharmacokinetic study in humans. J Pharmaceut Biomed Anal 40 (2006) 168-172
12. Chow S.-C., and Liu J.-P. Design and Analysis of Bioavailability and Bioequivalence Studies (1992), Marcel Dekker, New York, NY
13. Korea FDA. K-BE test 2002, Program Deliberation and Medication Committee (Korea), Registration No: 2002 01-12 1593.
14. Almeida S., Almeida A., Filipe A., et al. In vitro disintegration and dissolution and in vivo bioequivalence of two alendronate once-weekly formulations. Arzneimittelforschung 56 (2006) 84-89
15. Porras A.G., Holland S.D., and Gertz B.J. Pharmacokinetics of alendronate. Clin Pharmacokinet 36 (1999) 315-328
16. Lin J.H., Russel G., and Gertz B. Pharmacokinetics of alendronate: An overview. Int J Clin Pract 101 Suppl (1999) 18-26