The effect of fluvoxamine on the pharmacokinetics, safety, and tolerability of ramosetron in healthy subjects.
OBJECTIVE: To investigate the effects of multiple doses of fluvoxamine on the pharmacokinetics, safety, and tolerability of a single oral 10-mug dose of ramosetron. METHODS: This was a single-center, open, one-sequence cross-over study. On Day 1, healthy male and female subjects were administered a...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 64; no. 7; pp. 691 - 696 |
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| Autores principales: | , , , , |
| Formato: | equations & formulas research tables/charts Journal Article |
| Publicado: |
Springer Nature
Jul2008
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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=105655259&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105655259 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Jul2008 vid: 64 iid: 7 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 105655259 2009933491 10.1007/s00228-008-0466-x NLM18438654 105655259 ppf: 691 ppct: 5 formats: fmt: @attributes: type: P tig: atl: The effect of fluvoxamine on the pharmacokinetics, safety, and tolerability of ramosetron in healthy subjects. aug: au: Kadokura T den Adel M Krauwinkel WJJ Takeshige T Nishida A affil: Clinical Pharmacology, Astellas Pharma Inc., 3-17-1, Hasune, Itabashi-ku, Tokyo, 174-8612, Japan, takeshi.kadokura@jp.astellas.com. sug: subj: Antiemetics Pharmacokinetics Serotonin Uptake Inhibitors Pharmacokinetics Analysis of Variance Data Analysis Software Descriptive Statistics Drug Interactions Female Irritable Bowel Syndrome Therapy Male Pharmacy and Pharmacology Human Female Male ab: OBJECTIVE: To investigate the effects of multiple doses of fluvoxamine on the pharmacokinetics, safety, and tolerability of a single oral 10-mug dose of ramosetron. METHODS: This was a single-center, open, one-sequence cross-over study. On Day 1, healthy male and female subjects were administered a single dose of 10 mug ramosetron. Dosing of fluvoxamine started with an initial morning dose of 50 mg on Day 3, followed by a twice daily (12-h interval) dosing of 50 mg on Days 4-12. The morning dose on Day 11 was administered in combination with a single dose of 10 mug ramosetron. RESULTS: Co-administration of fluvoxamine with ramosetron resulted in an increase in the C(max) and AUC(0-inf) of ramosetron by 1.42-fold (90% CI 1.35-1.49) and 2.78-fold (90% CI 2.53-3.05), respectively. CONCLUSION: Co-administration of the CYP1A2 inhibitor fluvoxamine with ramosetron resulted in an interaction. However, the safety data collected during the study do not indicate that this interaction will cause any major safety concerns. pubtype: Academic Journal doctype: equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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