Healthy
Conditions
Brief summary
This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.
Interventions
DRUGZolmitriptan 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.
DRUGZolmitriptan 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.
Sponsors
Parc de Salut Mar
Food and Drug Administration (FDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Zolmitriptan on Heart Rate (HR). | 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). | 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) | Up to 24 hours | To assess the effects of Zolmitriptan on DBP; only results at 24 hours will be reported. |
| AUC(0-24h) | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effects (AE) | Up to 24 hours. | AE was performed including number and percentage. |
Countries
Spain
Participant flow
Recruitment details
From July 2023 to September 2023, participants were recruited from the Clinical Research Unit of Mar Hospital Research Institute database.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized | 24.7 Years STANDARD_DEVIATION 9.8 |
| Body Mass Index (BMI) | 22.2 kg/m^2 STANDARD_DEVIATION 2.5 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 8 | 4 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
None listed