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Completed

NCT Number: NCT06074016

Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

IMIM (Hospital del Mar Medical Research Institute)

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zolmitriptan intranasal.

Drug

Zolmitriptan nasal spray is supplied in a single-use, ready-to-use spray unit. It is administered in one nostril. The full protocol will explain how to use it. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.

Zolmitriptan oral.

Drug

Zolmitriptan 5 mg orally disintegrating tablet is to be taken without liquids. For oral administration, each tablet will be placed in the top of the tongue without any liquid and will disperse in a matter of seconds, then be swallowed with saliva. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.

Primary outcomes

  1. Effects of Zolmitriptan on Heart Rate (HR).

    Time frame: Up to 24 hours.

    To assess the effects of Zolmitriptan on HR; only results at 24 hours will be reported.

  2. Effects of Zolmitriptan on Systolic Blood Pressure (SBP).

    Time frame: Up to 24 hours.

    To assess the effects of Zolmitriptan on SBP; only results at 24 hours will be reported.

  3. Effects of Zolmitriptan Diastolic Blood Pressure (DBP)

    Time frame: Up to 24 hours

    To assess the effects of Zolmitriptan on DBP; only results at 24 hours will be reported.

  4. AUC(0-24h)

    Time frame: up to 24 hours

    Area under the curve from 0 time to the last measurable concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.

  5. Tmax

    Time frame: Blood samples were taken pre-dose and up to 24 hours after start of each Dose

    Time of maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.

  6. Cmax

    Time frame: Blood samples were taken pre-dose and up to 24 hours after start of each Dose

    The mean maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations

Secondary outcomes

  1. Adverse Effects (AE)

    Time frame: Up to 24 hours.

    AE was performed including number and percentage.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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