HealthyPhase 1NCT06074016
Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.
A Phase 1 study testing Zolmitriptan intranasal. and Zolmitriptan oral. in people with Healthy, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Zolmitriptan intranasal. and Zolmitriptan oral.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2023to 29 Sep 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.
- Conditions
- Healthy
- Being tested
- Zolmitriptan intranasal., Zolmitriptan oral.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Zolmitriptan intranasal. | Experimental | Not described Receives: Drug: Zolmitriptan intranasal. |
| Zolmitriptan oral. | Experimental | Not described Receives: Drug: Zolmitriptan oral. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Zolmitriptan on Heart Rate (HR).
To assess the effects of Zolmitriptan on HR; only results at 24 hours will be reported.
Measured: Up to 24 hours.
Effects of Zolmitriptan on Systolic Blood Pressure (SBP).
To assess the effects of Zolmitriptan on SBP; only results at 24 hours will be reported.
Measured: Up to 24 hours.
Effects of Zolmitriptan Diastolic Blood Pressure (DBP)
To assess the effects of Zolmitriptan on DBP; only results at 24 hours will be reported.
Measured: Up to 24 hours
AUC(0-24h)
Area under the curve from 0 time to the last measurable concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.
Measured: up to 24 hours
Tmax
Time of maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.
Measured: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
Cmax
The mean maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations
Measured: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
Secondary outcomes (1)
Adverse Effects (AE)
AE was performed including number and percentage.
Measured: Up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start12 Jul 2023
- Primary completion6 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074016
- Sponsor's protocol ID
- IMIMFCTL/ZOL_1
- Status last verified
- Jun 2023
- First submitted
- 12 Sep 2023
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06074016
- Acronym / sponsor ID
- IMIMFCTL/ZOL_1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolmitriptan intranasal. | Experimental | Drug: Zolmitriptan intranasal. |
| Zolmitriptan oral. | Experimental | Drug: Zolmitriptan oral. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolmitriptan intranasal.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. | Drug | Zolmitriptan intranasal. |
| Zolmitriptan oral.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. | Drug | Zolmitriptan oral. |
Primary outcome
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.
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.
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.
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.
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.
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
1 secondary outcome
Adverse Effects (AE)
Time frame: Up to 24 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zolmitriptan intranasal. and Zolmitriptan oral. in people with Healthy, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Zolmitriptan on Heart Rate (HR). (time frame: Up to 24 hours.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.