Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06074016
• Other study ID #: IMIMFCTL/ZOL_1
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2023
• Est. completion date: September 29, 2023

Study information

• Verified date: June 2023
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 29, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or female volunteers by physical examination, vital signs, ECG, and safety laboratory parameters and results must be within normal ranges or considered not clinically relevant by the investigator.

• Age = 18 years and = 55 years.

• Body mass index (BMI) = 18 and = 30.

• Able/willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine-containing items when outside the Clinical Research Unit (CRU)

• Able to read Spanish and adhere to study requirements.

• Informed consent signed before any procedure required by the study.

Exclusion Criteria:

• Smoking.

• History or clinically relevant diseases.

• Be under administrative or legal supervision.

• Pregnancy and breastfeeding.

• Positive blood or urine drug of abuse test or breathalyzer prior to study drug administration.

• Any history, disease, disorder, condition, anomaly or clinical finding that is relevant in the judgment of the investigator that may interfere with the study.

• Known hypersensitivity to any drug or excipient of the drug.

• Use of medications, inhibitors, any prescription or over-the-counter products, including herbs, homeopathy, vitamins, minerals, and nutritional supplements, before or during the study, that may interfere with the conduct and results of the study.

• Donation or transfusion of blood or plasma before, during or after study drug administration.

• History of inadequate venous access and/or experience of difficulty donating blood.

• Not being able/unwilling to accept restrictions regarding diet, physical exercise and consumption of alcohol and/or articles containing xanthine when outside the CRU.

• Subject included in a clinical study in the 3 months prior to the study drug administration.

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	IMIM (Hospital del Mar Medical Research Institute)	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Food and Drug Administration (FDA)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects.		Up to 24 hours.
Primary	Effects of zolmitriptan on heart rate (HR).		Up to 24 hours.
Primary	Effects of zolmitriptan on systolic and diastolic blood pressure (BP).		Up to 24 hours.
Secondary	Concentration of zolmitriptan on vasoactive intestinal polypeptide (VIP) in captures Day 1.		Up to 24 hours.