Open label, three period, single sequence, study of 5, 25, 50 mg sertraline pharmacokinetics in healthy male Korean volunteers

International Journal of Clinical Pharmacology and Therapeutics

Volumn 49, Issue 11, 2011, Pages 672-678

  Park, M K ^a   Shin, K H ^a   Kim, K P ^a   Kim, T E ^a   Yoon, S H ^a   Cho, J Y ^a   Shin, S G ^a   Jang, I J ^a   Yu, K S ^a  

^a Seoul National University College of Medicine   (South Korea)

Author keywords

Drug development; Pharmacokinetics; PK PD microdosing; Sertraline

Indexed keywords

SERTRALINE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE SEQUENCE; DRUG EFFECT; DRUG HALF LIFE; DRUG MICRODOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; GASTROINTESTINAL DISEASE; HEADACHE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; KOREA; LOW DRUG DOSE; MALE; MUSCULOSKELETAL DISEASE; MYALGIA; NEUROLOGIC DISEASE; NORMAL HUMAN; PARESTHESIA; SENSORY NEUROPATHY; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION;

ADULT; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; KOREA; MALE; MIDDLE AGED; SEROTONIN UPTAKE INHIBITORS; SERTRALINE; YOUNG ADULT;

EID: 80054789462     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201578     Document Type: Article

References (13)

1. Alderman J, Wolkow R, Chung M, Johnston HF. Sertraline treatment of children and adolescents with obsessive-compulsive disorder or depression: pharmacokinetics, tolerability, and efficacy. J Am Acad Child Adolesc Psychiatry. 1998; 37: 386-394. doi:10.1097/00004583-199804000-00016 PubMed (Pubitemid 28162892)
2. Benedetti MS, Whomsley R, Poggesi I, Cawello W, Mathy FX, Delporte ML, Papeleu P, Watelet JB. Drug metabolism and pharmacokinetics. Drug Metab Rev. 2009; 41: 344-390. doi:10.1080/10837450902891295 PubMed
3. Derendorf H, Lesko LJ, Chaikin P, Colburn WA, Lee P, Miller R, Powell R, Rhodes G, Stanski D, Venitz J. Pharmacokinetic/pharmacodynamic modeling in drug research and development. J Clin Pharmacol. 2000; 40: 1399-1418. PubMed
4. DeVane CL, Liston HL, Markowitz JS. Clinical pharmacokinetics of sertraline. Clin Pharmacokinet. 2002; 41: 1247-1266. doi:10.2165/00003088- 200241150-00002 PubMed (Pubitemid 36026765)
5. Garner RC, Lappin G. The phase 0 microdosing concept. Br J Clin Pharmacol. 2006; 61: 367-370. PubMed doi:10.1111/j.1365-2125.2006.02575.x
6. Goodnick PJ, Goldstein BJ. Selective serotonin reuptake inhibitors in affective disorders - I. Basic pharmacology. J Psychopharmacol. 1998; 12(Suppl B): 5-20. PubMed
7. Lappin G, Garner RC. Big physics, small doses: the use of AMS and PET in human microdosing of development drugs. Nat Rev Drug Discov. 2003; 2: 233-240. doi:10.1038/nrd1037 PubMed (Pubitemid 37361669)
8. Owens MJ, Morgan WN, Plott SJ, Nemeroff CB. Neurotransmitter receptor and transporter binding profile of antidepressants and their metabolites. J Pharmacol Exp Ther. 1997; 283: 1305-1322. PubMed (Pubitemid 28016506)
9. Saletu B, Grünberger J, Linzmayer L. On central effects of serotonin re-uptake inhibitors: quantitative EEG and psychometric studies with sertraline and zimelidine. J Neural Transm. 1986; 67: 241-266. PubMed doi:10.1007/ BF01243351
10. Vuong T, Ruckle JL, Blood AB, Reid MJ, Wasnich RD, Synal HA, Dueker SR. Use of accelerator mass spectrometry to measure the pharmacokinetics and peripheral blood mononuclear cell concentrations of zidovudine. J Pharm Sci. 2008; 97: 2833-2843. doi:10.1002/jps.21160 PubMed
11. Warrington SJ. Clinical implications of the pharmacology of sertraline. Int Clin Psychopharmacol. 1991; 6 (Suppl 2): 11-21. doi:10.1097/00004850- 199112002-00004 PubMed
12. Wilding IR, Bell JA. Improved early clinical development through human microdosing studies. Drug Discov Today. 2005; 10: 890-894. doi:10.1016/S1359- 6446(05)03509-9 PubMed
13. Wong DT, Bymaster FP, Horng JS, Molloy BB. A new selective inhibitor for uptake of serotonin into synaptosomes of rat brain: 3-(p-trifluoromethyl- phenoxy)- N-methyl-3-phenylpropylamine. J Pharmacol Exp Ther. 1975; 193: 804-811. PubMed