Evaluation of the Bioavailability of Methylprednisolone | Clinical Trial | StuddyBuddy@endsection Evaluation of the Bioavailability of Methylprednisolone
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Completed NCT05649878

Evaluation of the Bioavailability of Methylprednisolone

Conditions: Methylprednisone Administration, Intranasal Administration, Intravenous Administration, Healthy Subjects

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 8
Sponsor: Edda Sciutto Conde

Location: Mexico

Summary

This study is aimed to evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05649878). StuddyBuddy aggregates publicly available trial information.