Single-dose and multiple-dose pharmacokinetics and safety of telbivudine after oral administration in healthy Chinese subjects

Journal of Clinical Pharmacology

Volumn 46, Issue 9, 2006, Pages 999-1007

  Hu, Pei ^a   Jiang, Ji ^a   Wang, Hongyun ^a   Pietropaolo, Keith ^b   Chao, George C ^b   Brown, Nathaniel A ^b   Zhou, Xiao Jian ^b  

^a PEKING UNION MEDICAL COLLEGE HOSPITAL   (China)

^b Idenix Pharmaceuticals Inc   (United States)

Author keywords

Chinese subjects; Hepatitis B; Pharmacokinetics; Telbivudine

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; LIVER ENZYME; TELBIVUDINE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD CELL COUNT; CHINESE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOSE TIME EFFECT RELATION; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DOSE REGIMEN; DRUG EXCRETION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG URINE LEVEL; FATIGUE; FEMALE; HEPATITIS B VIRUS; HUMAN; HUMAN EXPERIMENT; KIDNEY CLEARANCE; MALE; MEDICAL ASSESSMENT; MULTIPLE DRUG DOSE; MUSCLE STRAIN; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; STEADY STATE;

ADMINISTRATION, ORAL; ADULT; CHINA; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG TOXICITY; FEMALE; HEALTH; HUMANS; MALE; NUCLEOSIDES; PYRIMIDINONES;

EID: 33747052308     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270006290623     Document Type: Article

References (17)

1. Margolis HS, Coleman PJ, Brown RE, Mast EE, Sheingold SH, Arevalo JA. Prevention of hepatitis B virus transmission by immunization. JAMA. 1995;274:1201-1208.
2. World Health Organization. Fact Sheet #204: Hepatitis B. 2000. Available at: http://www.who.int/mediacentre/factsheets/fs204/en/index.html. Accessed October 17, 2005.
3. Davey S. State of the world's vaccines and immunization. Geneva: World Health Organization; 1996. Available at: http://www.who.int/vaccines-documents/ DocsPDF/www9532.pdf. Accessed October 17, 2005.
4. Merican I, Guan R, Amarapuka D, Alexander MJ, Chutaputti A, Chien RN, et al. Chronic hepatitis B virus infection in Asian countries. J Gastroenterol Hepatol. 2000;15:1356-1361.
5. Mohamed R, Desmond P, Suh DJ, et al. Practical difficulties in the management of hepatitis B in the Asia-Pacific region. J Gastroenterol Hepatol. 2004;19:958-969.
6. Lok ASF, McMahon BJ. Chronic hepatitis B: update of recommendations. Hepatology. 2004;39:857-861.
7. US Food and Drug Administration. CDER Drugs@FDA. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/mdex.cfm. Accessed October 17, 2005.
8. FDA AdvisoryCommittee.com. Bristol entecavir post-marketing surveillance study would track cancer risk. Available at: http://www.fdaadvisorycommittee. com/FDC/AdvisoryCommitte/Committees/Antiviral+Drugs/031105_entecavir/ 031105_entecavirP.htm. Accessed October 17, 2005.
9. Bryant ML, Bridges EG, Placidi L, et al. Antiviral L-nucleosides specific for hepatitis B virus infection. Antimicrob Agents Chemother. 2001;45:229-235.
10. Lai CL, Lim SG, Brown NA, et al. A dose-finding study of once-daily oral telbivudine in HBeAg-positive patients with chronic hepatitis B virus infection. Hepatology. 2004;40:719-726.
11. Lai CL, Leung N, Teo EK, et al. A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B. Gastroenterology. 2005;129:528-536.
12. Zhou XJ, Lim SG, Lloyd DM, Chao GC, Brown NA, Lai CL. Pharmacokinetics of telbivudine following oral administration of escalating single and multiple doses in patients with chronic hepatitis B virus infection: pharmacodynamic implications. Antimicrob Agents Chemother. 2006;50:874-879.
13. Zhou XJ, Myers M, Chao G, Dubuc G, Brown NA. Clinical pharmacokinetics of telbivudine, a potent antiviral for hepatitis B, in subjects with impaired hepatic or renal function. Hepatology. 2004;40(suppl 1):672A.
14. Zhou XJ, Lim SG, Lai CL, Pow DM, Brown NA, Myers MW. Pharmacokinetics of B-L-deoxythymidine (LdT) in healthy subjects and patients with chronic hepatitis B virus infection. Presented at: Frontiers in Drug Development for Viral Hepatitis, December 2001, Maui, Hawaii. HepDart abstract 92.
15. Zhou XJ, Lloyd DM, Chao GC, Brown NA. Absence of food effect on the pharmacokinetics of telbivudine following oral administration in healthy subjects. J Clin Pharmacol. 2006;46:275-281.
16. Zhou XJ, Fielman BA, Lloyd DM, Chao GC, Brown NA. Pharmacokinetics of telbivudine in healthy subjects and the absence of drug interaction with lamivudine or adefovir dipivoxil. Antimicrob Agents Chemother. 2006;50:2309-2315.
17. Thongsawat S, Lai CL, Gane E, Chao G, Fielman B, Brown N, and the GLOBE Study Group. Telbivudine displays consistent antiviral efficacy across patient subgroups for the treatment of chronic hepatitis B: Results from the GLOBE Study. J Hepatology. 2006;44(suppl 2): S49.