Evaluation of the Bioavailability of Methylprednisolone

NCT ID: NCT05649878

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2021-11-12

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.

Conditions

Methylprednisone Administration; Intranasal Administration; Intravenous Administration; Healthy Subjects

Keywords

methylprednisolone; intranasal; pharmacokinetics; Bioavailability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intravenously MEP

Single dose of MEP sodium succinate intravenously administered. MEP (equivalent to 62.5 mg of Methylprednisolone).

Samples were obtained at 0.333, 0.50, 0.667, 0.833, 1, 1.0, 2, 3, 4, 6, 8, 10, 12 and 24 h after MEP administration.

Group Type: ACTIVE_COMPARATOR

Evaluation of bioavailability of methylprednisolone succinate administered intravenously

Intervention Type: DRUG

Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intravenously. The nominal doses were similar, volunteers were randomly assigned to receive a single dose of MEP by IV bolus of 1.5 mL. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.

Intranasally MEP

Volunteers were randomly assigned to receive a single dose of MEP intranasally administered (equivalent to 62.5 mg of Methylprednisolone), using a Mucosal Atomization Device (MAD Nasal). Samples were obtained at 0.333, 0.50, 0.667, 0.833, 1, 1.0, 2, 3, 4, 6, 8, 10, 12 and 24 h after MEP administration.

Group Type: ACTIVE_COMPARATOR

Evaluation of bioavailability of methylprednisolone succinate administered intranasally

Intervention Type: DRUG

Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intranasally. Volunteers were randomly assigned to receive a single dose of MEP intranasally by using a Mucosal Atomization Device (MAD Nasal). allowing direct pharmacokinetic comparison without dose normalization. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.

Interventions

Evaluation of bioavailability of methylprednisolone succinate administered intravenously

Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intravenously. The nominal doses were similar, volunteers were randomly assigned to receive a single dose of MEP by IV bolus of 1.5 mL. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.

Intervention Type: DRUG

Evaluation of bioavailability of methylprednisolone succinate administered intranasally

Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intranasally. Volunteers were randomly assigned to receive a single dose of MEP intranasally by using a Mucosal Atomization Device (MAD Nasal). allowing direct pharmacokinetic comparison without dose normalization. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Edda Sciutto Conde

OTHER

Sponsor Role: lead

Responsible Party

Edda Sciutto Conde

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Universidad Nacional Autonoma de Mexico

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

BE-PNO-049-F01

Identifier Type: -

Identifier Source: org_study_id