Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

Parc de Salut Mar

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Zolmitriptan intranasal.

Drug: Zolmitriptan oral.

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

IMIMFCTL/ZOL_1

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.