Evaluation of the Bioavailability of Methylprednisolone

NCT05649878 | Completed DMC

• 1 other identifier: BE-PNO-049-F01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Methylprednisone Administration; Intranasal Administration; Intravenous Administration; Healthy Subjects

Keywords

methylprednisolone; intranasal; pharmacokinetics; Bioavailability

Outcome Measures

Primary Outcomes (1)

• Absolute Bioavailability of Methylprednisolone, Intranasal Route vs. Intravenous Route

  The sample size used for this exploratory study (descriptive, comparative or informative) made it possible to determine the absolute bioavailability (with informative value), for which the bioavailability was compared in the 2 types of administration: Intranasal vs. Intravenous with a sample size of 8 research subjects, even though the ANADEVA is informative, the requirements regarding type I error (alpha), type II error (beta) and a minimum difference to detect between the 2 routes of administration: intranasal vs. IV. The realization of the present study allowed to know the pharmacokinetic and safety parameters of the drug MEP administered by 2 different routes, as well as to determine the CVintra%

  2 weeks

Study Arms (2)

Intravenously MEP

ACTIVE COMPARATOR

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.

Drug: Evaluation of bioavailability of methylprednisolone succinate administered intravenously

Intranasally MEP

ACTIVE COMPARATOR

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.

Drug: Evaluation of bioavailability of methylprednisolone succinate administered intranasally

Interventions

Evaluation of bioavailability of methylprednisolone succinate administered intravenously 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.

Intravenously MEP

Evaluation of bioavailability of methylprednisolone succinate administered intranasally 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.

Intranasally MEP

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edda Sciutto Conde: lead

Study Sites (1)

Universidad Nacional Autonoma de Mexico

Mexico City, 04510, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 14, 2022
• Study Start: November 5, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 12, 2021
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)