Pharmacokinetics and pharmacodynamics of single-dose oral tolvaptan in fasted and non-fasted states in healthy Caucasian and Japanese male subjects.
Purpose: To compare the pharmacokinetics and pharmacodynamics of tolvaptan in Caucasian and Japanese healthy male subjects under fasting and non-fasting conditions. Methods: This was a single-center, parallel-group, randomized, open-label, three-period crossover trial of single oral doses of tolvapt...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 68; no. 12; pp. 1595 - 1604 |
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| Autores principales: | , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Dec2012
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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=104436762&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104436762 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Dec2012 vid: 68 iid: 12 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 104436762 83372384 10.1007/s00228-012-1295-5 NLM22585285 104436762 ppf: 1595 ppct: 9 formats: fmt: @attributes: type: P tig: atl: Pharmacokinetics and pharmacodynamics of single-dose oral tolvaptan in fasted and non-fasted states in healthy Caucasian and Japanese male subjects. aug: au: Shoaf, Susan Kim, Seong Bricmont, Patricia Mallikaarjun, Suresh affil: Clinical Pharmacology, Otsuka Pharmaceutical Development & Commercialization, Inc, 2440 Research Blvd. Rockville 20850 USA sug: subj: Metabolism Ethnology White Persons Japanese Persons Heterocyclic Compounds Pharmacokinetics Heterocyclic Compounds Pharmacodynamics Hyponatremia Drug Therapy Food Intake Crossover Design Preprocedural Fasting Male Human Descriptive Statistics Confidence Intervals Heterocyclic Compounds Urine Heterocyclic Compounds Blood Young Adult Adult Middle Age Random Assignment Linear Regression Chromatography, High Pressure Liquid Adverse Drug Event Funding Source Adult: 19-44 years Middle Aged: 45-64 years Male ab: Purpose: To compare the pharmacokinetics and pharmacodynamics of tolvaptan in Caucasian and Japanese healthy male subjects under fasting and non-fasting conditions. Methods: This was a single-center, parallel-group, randomized, open-label, three-period crossover trial of single oral doses of tolvaptan 30 mg under fasting and non-fasting [a high-fat, high-calorie meal (HFM) or Japanese standard meal] conditions in 25 healthy male Caucasian subjects and 24 healthy male Japanese subjects. Pharmacodynamic endpoints were urine volume and fluid balance for 0 to 24 h postdose. Results: In the fasted state, the plasma tolvaptan C and AUC geometric mean ratios (90 % confidence interval) were 1.105 (0.845-1.444) and 1.145 (0.843-1.554) for Japanese compared to Caucasian subjects. A HFM increased the C and AUC values by about 1.15-fold in both Japanese and Caucasian subjects.. Twenty-four-hour urine volumes paralleled pharmacokinetic changes, but the increases were not clinically significant. Fluid balance in the Japanese men was 1.4- to 2.0-fold more negative than that in the Caucasian men. Conclusion: Tolvaptan pharmacokinetics is not clinically significantly affected by race. Body weight is a factor that affects exposure. Tolvaptan can be administered with or without food. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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