Comparative study on the bioequivalence of two formulations of pioglitazone tablet in healthy Thai male volunteers

Drug Development and Industrial Pharmacy

Volumn 33, Issue 12, 2007, Pages 1362-1368

  Sripalakit, Pattana ^a   Maphanta, Sirada ^a   Neamhom, Penporn ^a   Saraphanchotiwitthaya, Aurasorn ^a   Polnok, Sanglar ^a   Yokubol, Dhirayudh ^a  

^a NARESUAN UNIVERSITY   (Thailand)

Author keywords

Add on subject study; Bioequivalence; Pharmacokinetics; Pioglitazone

Indexed keywords

GLUBOSIL; PIOGLITAZONE; UNCLASSIFIED DRUG;

ADD ON THERAPY; ADULT; ARTICLE; BIOEQUIVALENCE; BLOOD LEVEL; BLOOD SAMPLING; CHEMICAL INDUSTRY; CLINICAL ARTICLE; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG FORMULATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; SINGLE DRUG DOSE; STATISTICAL SIGNIFICANCE;

ADOLESCENT; ADULT; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; HUMANS; MALE; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY; THIAZOLIDINEDIONES;

EID: 37549040984     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.1080/03639040701484155     Document Type: Article

References (11)

1. Chilcott, J., Tappenden, P., Lloyd, M., & Wight, J. P. (2001). A systematic review of the clinical effectiveness of pioglitazone in the treatment of type 2 diabetes mellitus. Clin. Ther., 23(11), 1792-1823. 10.1016/S0149-2918(00)80078-8
2. Diletti, E., Hauschke, D., & Steinijans V. W. (1991). Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol., 29(1), 1-8. www.springerlink. com/index/L313161208061321.pdf
3. Eckland, D. A., & Danhof, M. (2000). Clinical pharmacokinetics of pioglitazone. Exp. Clin. Endocrinol. Diabetes, 108(2), 234-242. 10.1055/s-2000-8525
4. Hanefeld, M. Pharmacokinetics and clinical efficacy of pioglitazone. Int. J. Clin. Pract. Suppl. 121, 19-25. 10.1055/s-2000-8525
5. Sripalakit, P.; Neamhom, P.; Saraphanchotiwitthaya, A. (2006). High-performance liquid chromatographic method for the determination of pioglitazone in human plasma using ultraviolet detection and its application to a pharmacokinetic study. J. Chrom. B 843(2), 164-169. 10.1016/j.jchromb.2006.05.032
6. Takeda Pharmaceutical Co. Ltd. (2004). Actos® (pioglitazone hydrochloride) full prescribing information, Osaka, Japan. http://www.actos.com
7. Thailand Food and Drug Administration. (2001). Guidelines for the conduct of bioavailability and bioequivalence studies. Drug Control Division, Ministry of Public Health, Thailand. www.app1.fda.moph.go.th/be/ guideline/Thailand/BABE/guideline.doc
8. US Food and Drug Administration. (2000). Guidance for industry: Bioavailability and bioequivalence studies for administered drug products-general considerations. Center for Drug Evaluation and Research, Rockville, MD. www.springerlink.com/index/V628675G42232436.pdf
9. Waugh, J., Keating, G. M., Plosker, G. L., Easthope, S., Robinson, D. M. (2006). Pioglitazone: A review of its use in type 2 diabetes mellitus. Drugs, 66(1), 85-109. www.medscape.com/viewarticle/550547_6
10. Wong, H., Ozalp, Y., Lainesse, A., Alpan, R. S. (2004). In vivo bioequivalence of oral antidiabetic agents: pioglitazone tablets. Arzneimittelforschung, 54(9), 618-624. www.druglib.com/abstract/wo/ wongh_arzneimittelforschung_20040900.html
11. World Health Organization. (2005). Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Switzerland. www.pharmexcil.com/v1/docs/TechSes-I/8.