IMIM (Hospital del Mar Medical Research Institute)
Barcelona, 08003, Spain
NCT Number: NCT06074016
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Barcelona, 08003, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 24 hours.
To assess the effects of Zolmitriptan on HR; only results at 24 hours will be reported.
Time frame: Up to 24 hours.
To assess the effects of Zolmitriptan on SBP; only results at 24 hours will be reported.
Time frame: Up to 24 hours
To assess the effects of Zolmitriptan on DBP; only results at 24 hours will be reported.
Time frame: up to 24 hours
Area under the curve from 0 time to the last measurable concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.
Time frame: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
Time of maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.
Time frame: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
The mean maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations
Time frame: Up to 24 hours.
AE was performed including number and percentage.
Parc de Salut Mar
Other
Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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