Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

• Status: Completed
• Trial end date: 2023-09-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Parc de Salut Mar
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Oxazolidinones; Zolmitriptan

Criteria

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.