Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Zolmitriptan intranasal.; Drug: Zolmitriptan oral.

• Registration Number: NCT06074016
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-07-12
• Primary Completion: 2023-09-06
• Study First Submitted: 2023-09-12
• Study Completion: 2023-09-29
• Study First Submitted QC: 2023-10-05
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zolmitriptan intranasal.	Zolmitriptan intranasal.	-
Zolmitriptan oral.	Zolmitriptan oral.	-

Primary Outcome Measures

Name	Time	Method
Effects of zolmitriptan on heart rate (HR).	Up to 24 hours.
Effects of zolmitriptan on systolic and diastolic blood pressure (BP).	Up to 24 hours.

Secondary Outcome Measures

Name	Time	Method
Concentration of zolmitriptan on vasoactive intestinal polypeptide (VIP) in captures Day 1.	Up to 24 hours.

Trial Locations

Locations (1)

IMIM (Hospital del Mar Medical Research Institute); 🇪🇸 Barcelona, Spain