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Phase 1 N=8 Randomized Treatment

Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

Healthy

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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