Pharmacodynamic comparison of two formulations of Acarbose 100-mg tablets

Journal of Clinical Pharmacy and Therapeutics

Volumn 37, Issue 5, 2012, Pages 553-557

  Lee, S ^a   Chung, J Y ^b   Hong, K S ^c   Yang, S H ^a   Byun, S Y ^a   Lim, H S ^d   Shin, S G ^a   Jang, I J ^a   Yu, K S ^a  

^a Seoul National University   (South Korea)

^b Yonsei University   (South Korea)

^c Seoul National University Hospital   (South Korea)

^d University of Ulsan   (South Korea)

Author keywords

Acarbose; bioequivalence; diabetes; non systemic; pharmacodynamics

Indexed keywords

ACARBOSE; GENERIC DRUG; GLUCOSE; PLACEBO; SUCROSE;

ABDOMINAL DISCOMFORT; ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CONFIDENCE INTERVAL; CONTROLLED STUDY; DRUG FORMULATION; GLUCOSE BLOOD LEVEL; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PHARMACODYNAMICS; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

ACARBOSE; ADULT; AREA UNDER CURVE; BLOOD GLUCOSE; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; HUMANS; MALE; PILOT PROJECTS; TABLETS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 84865861795     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/j.1365-2710.2012.01339.x     Document Type: Article

References (16)

1. van de Laar FA, Lucassen PL, Akkermans RP, van de Lisdonk EH, Rutten GE, van Weel C,. Alpha-glucosidase inhibitors for patients with type 2 diabetes: results from a Cochrane systematic review and meta-analysis. Diabetes Care, 2005; 28: 154-163. (Pubitemid 40095800)
2. Lebovitz HE,. Alpha-glucosidase inhibitors. Endocrinol Metab Clin North Am, 1997; 26: 539-551. (Pubitemid 27410890)
3. Bischoff H,. The mechanism of alpha-glucosidase inhibition in the management of diabetes. Clin Invest Med, 1995; 18: 303-311. (Pubitemid 26004877)
4. Rosak C, Mertes G,. Effects of acarbose on proinsulin and insulin secretion and their potential significance for the intermediary metabolism and cardiovascular system. Curr Diabetes Rev, 2009; 5: 157-164.
5. Jenkins DJ, Taylor RH, Goff DV, et al. Scope and specificity of acarbose in slowing carbohydrate absorption in man. Diabetes, 1981; 30: 951-954.
6. Koytchev R, Richter W, Erkent U, et al. Influence of acarbose on blood glucose and breath hydrogen after carbohydrate load with sucrose or starch. Arzneimittelforschung, 2009; 59: 557-563.
7. Bayer HealthCare Pharmaceuticals Inc. PRECOSE® (acarbose tablets). Montville, NJ: Bayer HealthCare Pharmaceuticals Inc, 2008.
8. Bayer HealthCare Pharmaceuticals Inc. Glucobay®. Montville, NJ: Bayer HealthCare Pharmaceuticals Inc, 2007.
9. Ahr HJ, Boberg M, Krause HP, et al. Pharmacokinetics of acarbose. Part I: absorption, concentration in plasma, metabolism and excretion after single administration of [14C]acarbose to rats, dogs and man. Arzneimittelforschung, 1989; 39: 1254-1260. (Pubitemid 19255301)
10. US Food and Drug Administration. Guidance for industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. White Oak, MD: US Food and Drug Administration, 2003.
11. Du Souich P, Besner JG, Caille G,. Pharmacodynamics as a tool to assess the bioequivalence of non-systemically available drugs: size of the sample required. Biopharm Drug Dispos, 1992; 13: 233-242.
12. Stewart BA, Ahrens RC, Carrier S, et al. Demonstration of in vivo bioequivalence of a generic albuterol metered-dose inhaler to Ventolin. Chest, 2000; 117: 714-721. (Pubitemid 30152210)
13. Korea Food and Drug Administration. Guidance for bioequivalence studies. Osong, South Korea: Korea Food and Drug Administration, 2008.
14. Haidar SH, Davit B, Chen ML, et al. Bioequivalence approaches for highly variable drugs and drug products. Pharm Res, 2008; 25: 237-241.
15. Committee for Proprietary Medicinal Products (CPMP) the European Agency for the Evaluation of Medicinal Products (EMEA). Note for guidance on the investigation of bioavailability and bioequivalence. London, UK: Committee for Proprietary Medicinal Products (CPMP) the European Agency for the Evaluation of Medicinal Products (EMEA), 2001.
16. US Food and Drug Administration. Draft guidance on acarbose. White Oak, MD: US Food and Drug Administration, 2009.