In vivo bioequivalence of oral antidiabetic agents: Pioglitazone tablets

Arzneimittel-Forschung/Drug Research

Volumn 54, Issue 9 A, 2004, Pages 618-624

  Wong, Hong ^a   Ozalp, Yildiz ^b   Lainesse, Audrey ^a   Alpan, Recep Serdar ^b,c  

^a Anapharm Canada   (Canada)

^b EIS Eczacibasi Ilac Sanayi ve T   (Turkey)

^c Eczacibasi Ilac Pazarlama   (Turkey)

Author keywords

CAS 112529 15 4; Pioglitazone, bioequivalence, clinical pharmacokinetics

Indexed keywords

DRUG METABOLITE; GENERIC DRUG; HYDROXYPIOGLITAZONE; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SCREENING; DRUG TOLERANCE; HUMAN; IN VIVO STUDY; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MAXIMUM ALLOWABLE CONCENTRATION; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; TABLET FORMULATION;

EID: 4644324595     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1297059     Document Type: Article

References (9)

1. Lehmann, J., Moore, L., Smith-Oliver, T. et al., An antidiabetic thiazolidinedione is a high affinity ligand for peroxisome proliferator- activated receptor γ (PPAR γ). J. Biol. Chem. 270, 12953 (1995)
2. Sandouk, T., Reda, D., Hofman, C., The antidiabetic agent pioglitazone increases expression of glucose transporters in 3T3-F442A cells by increasing messenger ribonucleic acid transcript stability. Endocrinology 133, 352 (1993)
3. Motojima, K., Passilly, P., Peters, J., Expression of putative fatty acid transporter genes are regulated by peroxisome proliferator-activated receptor α and γ activators in a tissue- and inducer specific manner. J. Biol. Chem. 273, 16710 (1998)
4. Gillies, P., Dunn, Ch,. Pioglitazone. Drugs 60, 333 (2000)
5. Nowak, S., Edwards, D., Clarke, A., et. al., Pioglitazone: effect on CYP3A4 activity. J. Clin. Pharmacol. 42, 1299 (2002)
6. Edwards, G., Eckland, D., Pharmacokinetics of pioglitazone in patients with renal impairment. Diabetologia 48 (Suppl. 1), A230 (1999) [abstract]
7. Hanefeld, M. Pharmacokinetics and clinical efficacy of pioglitazone. Int. J. Clin. Pract. Suppl. 121, 19 (2001)
8. CPMP Note for guidance: Investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1401/98 (1998)
9. Eckland, D., Danhoh, M., Clinical pharmacokinetics of pioglitazone. Exp. Clin. Endocrinol. Diabetes. 108 (Suppl. 2), S234 (2000)