Evaluation of the Bioavailability of Methylprednisolone

Launched by EDDA SCIUTTO CONDE · Dec 5, 2022

Keywords

ClinConnect Summary

The most important property of a drug dosage is its ability to deliver the active ingredient to the site of action in a quantity sufficient to exert the expected pharmacological effect. This ability is known as bioavailability. Methylprednisolone is a drug with wide clinical use in patients with inflammatory pathologies (infectious or non-infectious). The main routes of administration are oral and intravenous. The intranasal route could be one more effective, less invasive that would allow to obtain a faster therapeutic concentration and in greater concentration in the lungs and in the cent...

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Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 55 years. Clinically healthy. Body mass index between 18.0 and 27.0 Kg/m2. Negative results to detect the presence of human immunodeficiency virus \[HIV\], Hepatitis B \[HBV\], Hepatitis C \[HCV) and test for detection of Syphilis (VDRL).
• • Subjects with negative results in tests for the detection of drugs of abuse such as: amphetamines, benzodiazepines, cocaine, methamphetamines, morphine and tetrahydro-cannabinoids.
• • Negative (qualitative) pregnancy test.
• Exclusion Criteria:
• • Subjects with any condition or alteration of the nose or nasal mucosa. Subjects with a history of hypersensitivity to the study drug. Subjects with a history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic disorders (any type of anemia), mental illness or other organic abnormalities that could affect the pharmacokinetic study of the product under study.
• • Subjects who require any medication during the course of the study. Principal Investigator will not include the subject in the study. Subjects who have been hospitalized for any reason within the sixty days prior to the start of the study or who have been seriously ill within the thirty days prior to the start of the study.
• • Subjects who have received an investigational drug within ninety days prior to the start of the study.
• • Subjects who have donated or lost 450 ml or more of blood within the ninety days prior to the start of the study.
• • Subjects who have smoked tobacco, ingested alcohol, consumed beverages or foods containing xanthines.
• • Positive (qualitative) pregnancy test.