Pharmacokinetics and tolerability of modafinil tablets in Chinese subjects.
OBJECTIVE: To investigate the pharmacokinetics and tolerability of modafinil in Chinese subjects. METHODS: Twelve healthy volunteers were given an escalating single dose of modafinil (100, 200 and 400 mg) in a three-period study (study 1). Another 12 volunteers received 100 mg twice daily for 7 days...
| Publicado en: | Journal of Clinical Pharmacy & Therapeutics Vol. 33; no. 4; pp. 429 - 438 |
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| Autores principales: | , , , , , |
| Formato: | clinical trial research Journal Article |
| Publicado: |
Wiley-Blackwell
Aug2008
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105814587&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105814587 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 02694727 EV4 jtl: Journal of Clinical Pharmacy & Therapeutics issn: 02694727 maglogo: Y pubinfo: dt: Aug2008 vid: 33 iid: 4 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 105814587 2010011977 10.1111/j.1365-2710.2008.00934.x NLM18613861 105814587 ppf: 429 ppct: 9 formats: fmt: @attributes: type: P tig: atl: Pharmacokinetics and tolerability of modafinil tablets in Chinese subjects. aug: au: Xu P Li HD Zhang BK Xiao YW Yuan HY Zhu YG affil: Clinical Pharmacy & Pharmacology Research Institute, the Second Xiangya Hospital of Central South University, Changsha, Hunan Province, China. sug: subj: Benzhydryl Compounds Pharmacokinetics Central Nervous System Stimulants Pharmacokinetics Adult Asians Benzhydryl Compounds Administration and Dosage Benzhydryl Compounds Adverse Effects Central Nervous System Stimulants Administration and Dosage Central Nervous System Stimulants Adverse Effects Dose-Response Relationship, Drug Double-Blind Studies Drug Administration Schedule Female Pharmacokinetics Time White Persons Human Adult: 19-44 years Female ab: OBJECTIVE: To investigate the pharmacokinetics and tolerability of modafinil in Chinese subjects. METHODS: Twelve healthy volunteers were given an escalating single dose of modafinil (100, 200 and 400 mg) in a three-period study (study 1). Another 12 volunteers received 100 mg twice daily for 7 days in multiple-dose study (study 2). Blood samples were taken from 0 to 60 h for study 1. And samples for study 2 were collected before administration on three consecutive morning and then from 0 to 60 h after the last dose. Pharmacokinetic parameters were calculated and compared with results from published data. RESULTS: In study 1, C(max) and area under the concentration-time curve of modafinil and modafinil acid were increased proportionally with dose levels; t(1/2) was independent on the dose levels. In study 2, the steady state was reached on day 4, and mean trough plasma concentration of modafinil was 1.36 +/- 0.34 mug/mL. Apparent plasma clearance and apparent volume of distribution were lower in 100 mg twice-daily group than those in 100 mg single group. The adverse events were mild and moderate in study 1 and 2. CONCLUSIONS: In this pharmacokinetic study, modafinil was safe and well tolerated by young healthy Chinese subjects. The major pharmacokinetic parameters of modafinil in Chinese subjects are similar to those reported in Caucasians although the half-life seems to be longer in the former than in the latter. This apparent difference requires investigation. pubtype: Academic Journal doctype: clinical trial research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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