NCT06074016

Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zolmitriptan intranasal.	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.
DRUG	Zolmitriptan oral.	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.

Timeline

• Start date: 2023-07-12
• Primary completion: 2023-09-06
• Completion: 2023-09-29
• First posted: 2023-10-10
• Last updated: 2025-07-31

Locations

1 site across 1 country: Spain