Phase 1
N=8
Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT06074016 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Effects of Zolmitriptan on Heart Rate (HR). — 64.4; 71.7 lpm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Zolmitriptan intranasal. (Drug); Zolmitriptan oral. (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Parc de Salut Mar
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of Zolmitriptan on Heart Rate (HR). |
64.4; 71.7 | — |
| PRIMARY Effects of Zolmitriptan on Systolic Blood Pressure (SBP). |
111.7; 111.7 | — |
| PRIMARY Effects of Zolmitriptan Diastolic Blood Pressure (DBP) |
63.4; 64.1 | — |
| PRIMARY AUC(0-24h) |
53.6; 44.3 | — |
| PRIMARY Tmax |
4; 4 | — |
| PRIMARY Cmax |
6.82; 5.71 | — |
| SECONDARY Adverse Effects (AE) |
1; 4 | — |
Summary
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT06074016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.