Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

The requested reference [d7fac657387abba5a39700c739136277d33904f3] no longer exists in our database. It has been replaced by the current reference: [5095d2b9a9f7141a2d10b644142ce70dca0e5290]

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
Interventional Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). Phase 1 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. Healthy Drug: Zolmitriptan intranasal.;Drug: Zolmitriptan oral. Effects of zolmitriptan on heart rate (HR).;Effects of zolmitriptan on systolic and diastolic blood pressure (BP). Concentration of zolmitriptan on vasoactive intestinal polypeptide (VIP) in captures Day 1.
Epistemonikos ID: 4c66280d83fb7d10ab2720ba19bd18b295e065df
First added on: May 15, 2024