A Phase 1 interventional study of PF-04531083 and simvastatin in Chronic Pain, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-04.
Sponsored by Pfizer · Phase 1 and Interventional
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.
observational- quantify any effects of PF_04531083 on the PK of Simvastatin
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PF-04531083 · Drug: simvastatin
Drug: PF-04531083 · Drug: simvastatin
PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
Pharmacokinetics of simvastatin. AUC, Cmax and half life.
Time frame: days 1 and 14 of study
Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.
Time frame: days 1 and 14 of study
Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing
Time frame: days 2, 4, 7, 11 and 14 of the study
safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events
Time frame: days 1 and 15 of the study
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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