Status:
COMPLETED
Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.
Lead Sponsor:
Parc de Salut Mar
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06074016
Start Date
July 12 2023
End Date
September 29 2023
Last Update
July 31 2025
Active Locations (1)
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1
IMIM (Hospital del Mar Medical Research Institute)
Barcelona, Spain, 08003