A Phase 1 interventional study of Commercial tablet with water and ODT #1 without water in Healthy Volunteers, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 1 site in Singapore. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 1, Interventional, and Basic science
The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Eletriptan commercial tablet given with water
Drug: Commercial tablet with water
Oral disintegrating tablet formulation #1 without water
Drug: ODT #1 without water
Oral disintegrating tablet formulation #2 without water
Drug: ODT #2 without water
Oral disintegrating tablet formulation (ODT) #1 with water
Drug: ODT #1 with water
Oral disintegrating tablet formulation (ODT) #2 with water
Drug: ODT #2 with water
40 mg tablet, given once to each subject
40 mg tablet given once to each subject
40 mg tablet given once to each subject
40 mg tablet given once to each subject
40 mg tablet given once to each subject
Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)
Time frame: 24 hr
Time of peak eletriptan concentrations (Tmax), half life
Time frame: 24 hr
Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests
Time frame: 3 weeks
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.