Clinical trial NCT05649878: Evaluation of the Bioavailability of Methylprednisolone
Official title: Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methylprednisone Administration
Intranasal Administration
Intravenous Administration
Healthy Subjects
Keywords: methylprednisolone
intranasal
pharmacokinetics
Bioavailability
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A single dose design was used, with 8 subjects under fasting conditions, two periods, two sequences, open, crossed with blocks scheme A-B and B-A, randomized, longitudinal, comparative and prospective, with a washout period of seven days between the two study sessions. The treatment groups were balanced, having an equal number of subjects who were randomly assigned to the administration sequences of the drug under study.

MEP sodium succinate was administered intravenously (1 mL, equivalent to 62.5 mg of Methylprednisolone) or the same dose intranasally by 2 using a Mucosal Atomization Device (MAD Nasal).

The nominal doses were similar, allowing direct pharmacokinetic comparison without dose normalization. Venous blood samples were obtained via an indwelling catheter before administration at different times. Plasma was separated and frozen at -70 °C for further analysis.
Primary purpose: OTHER

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

Detailed description: 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 central nervous system than the intravenous route, maintaining very similar systemic concentrations to those achieved intravenously. For these reasons, it is important to know the bioavailability of methylprednisolone administered by this route in order to establish the best dosing regimen. The pilot study is of an exploratory nature (descriptive, comparative or informative), whose objective is to know the pharmacokinetic characteristics of a new route of administration of a drug in the study population to establish the pharmacokinetic parameters, and the comparison between the intranasal bioavailability against the intravenous administration by determining confidence intervals and calculating one-sided double t of Scuirmann.

Objetive: To evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous dose of 1 ml of methylprednisolone sodium succinate equivalent to 62.5 mg of methylprednisolone.

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.

Primary outcomes:
measure: Absolute Bioavailability of Methylprednisolone, Intranasal Route vs. Intravenous Route
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Universidad Nacional Autonoma de Mexico
Study officials:
References: