Clinical Research Directory

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.