At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Zolmitriptan intranasal. and Zolmitriptan oral. for Healthy. Completed, enrolled 8 participants across 1 site.
Detailed Summary
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.
Study Details
Timeline
Interventions
Zolmitriptan nasal spray is supplied in a single-use, ready-to-use spray unit. It is administered in one nostril. The full protocol will explain how to use it. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.
Zolmitriptan 5 mg orally disintegrating tablet is to be taken without liquids. For oral administration, each tablet will be placed in the top of the tongue without any liquid and will disperse in a matter of seconds, then be swallowed with saliva. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.