Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

July 12, 2023

Primary Completion Date

September 6, 2023

Study Completion Date

September 29, 2023

Conditions
Healthy
Interventions
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.

Trial Locations (1)

08003

IMIM (Hospital del Mar Medical Research Institute), Barcelona

All Listed Sponsors
collaborator

Food and Drug Administration (FDA)

FED

lead

Parc de Salut Mar

OTHER