Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan. (NCT06074016) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.
Spain8 participantsStarted 2023-07-12
Plain-language summary
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 difficult…
What they're measuring
1
Effects of Zolmitriptan on Heart Rate (HR).
Timeframe: Up to 24 hours.
2
Effects of Zolmitriptan on Systolic Blood Pressure (SBP).
Timeframe: Up to 24 hours.
3
Effects of Zolmitriptan Diastolic Blood Pressure (DBP)
Timeframe: Up to 24 hours
4
AUC(0-24h)
Timeframe: up to 24 hours
5
Tmax
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
6
Cmax
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each Dose