Pharmacokinetic and pharmacodynamic population modeling of orally administered rabeprazole in healthy Chinese volunteers by the NONMEM method

European Journal of Drug Metabolism and Pharmacokinetics

Volumn 31, Issue 1, 2006, Pages 27-33

  Chen, Zhi Yang ^a   Xie, Hai Tang ^b   Zheng, Qing Shan ^c   Sun, Rui Yuan ^c   Hu, Gang ^a  

^a NANJING MEDICAL UNIVERSITY   (China)

^b CHINA PHARMACEUTICAL UNIVERSITY   (China)

^c Anhui Provincial Center of Drug Clinical Evaluation   (China)

Author keywords

NONMEM; Pharmacokinetic pharmacodynamic population modeling; Population approach; Rabeprazole

Indexed keywords

CYTOCHROME P450 2C19; RABEPRAZOLE;

ADULT; ARTICLE; CHINESE; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; COMPUTER PROGRAM; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG ELIMINATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MALE; RANDOMIZED CONTROLLED TRIAL; STOMACH PH;

EID: 33646672638     PISSN: 03787966     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03190639     Document Type: Article

References (15)

1. Vo L, Simonian HP, Doma S, Fisher RS, Parkman HP. (2005): The effect of rabeprazole on regional gastric acidity and the postprandial cardio/gastro-oesophageal junction acid layer in normal subjects: a randomized, double-blind, placebo-controlled study. Alimentary Pharmacology & Therapeutics 21 (11), 1321-1330
2. 2 antagonist therapy. Anesthesia and analgesia, 101(4), 1038-1041
3. Robinson M. (2005): Proton pump inhibitors: update on their role in acid-related gastrointestinal diseases. International journal of clinical practice 59(6), 709-715
4. 2 receptor blocker on intragastric pH: a pilot study. The Turkish journal of gastroenterology, 15(4), 225-228
5. Zheng X.-Y. et al (1999): Guideline of new chemical drugs' development and application: part I. Clinical Pharmacokinetics.
6. Chen Z.-Y., Zheng Q.-S., Sun R.-Y. (2002): Introduction to the main functions of DAS pharmacological software. Chinese Journal of Clinical Pharmacology and Therapeutics, 7, 562-564
7. Zheng Q.-S., Sun R.-Y., Chen Z.-Y. (2003): Lowest sample size and its safety in clinical trials in China. Chinese Journal of Clinical Pharmacology and Therapeutics 3, 354-355
8. Ando T, Kato H, Sugimoto N, Nagao Y, Seto N, Kongo H, Kajikawa H, Isozaki Y, Shimozawa M, Naito Y, Yoshida N, Ishizaki T, Yoshikawa T. (2005): A comparative study on endoscopic ulcer healing of omeprazole versus rabeprazole with respect to CYP2C19 genotypic differences. Digestive diseases and sciences 50(9), 1625-1631
9. Hu YM, Xu JM, Mei Q, Xu XH, Xu SY. (2005): Pharmacodynamic effects and kinetic disposition of rabeprazole in relation to CYP2C19 genotype in healthy Chinese subjects. Acta pharmacologica Sinica 26(3), 384-388
10. Jun Chen, Wen Ming Jiang, Xiao Ling Gao, Xinguo Jiang, Qi Zhi Zhang, Zhao Hua Zheng (2005): Bioequivalence evaluation of two rabeprazole enteric coated formulations in healthy Chinese volunteers. Eur J Drug Metab Pharmacokinetics 29(2), 103-106
11. Beal S.L., Sheiner L.B., (Eds) (1989-1998): User Guide, part I- VIII. Globomax LLC, Hanover, MD, USA.
12. Merle Y., Tod M. (2001): Impact of pharmacokinetic- pharmacodynamic model linearization on the accuracy of population information matrix and optimal design. Journal of Pharmacokinetics and Pharmacodynamics 28(4), 363-388
13. Chuanpu Hu, Katy H. P. Moore, Yong H. Kim, Mark E. Sale (2004): Statistical issues in a modeling approach to assessing bioequivalence or PK similarity with presence of sparsely sampled subjects. Journal of Pharmacokinetics and Pharmacodynamics 31(4), 321-339
14. Setoyama T, Laurent A, Humphries T, Hasegawa J. (2005): Pharmacokinetics of rabeprazole following single intravenous and oral administration to healthy subjects. International journal of clinical pharmacology and therapeutics 43(1), 37-42
15. Beal S.L., Sheiner L.B. (1998): Handout, Intermediate Workshop in Population Pharmacokinetic Data Analysis Using the NONMEM System (Lecture 3, page 5). San Francisco, April 23-24, 1998