Evaluation of the Bioavailability of Methylprednisolone
Condition: Methylprednisone Administration; Intranasal Administration; Intravenous Administration; Healthy Subjects
Study type: Interventional

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.
    

Intervention name(s): Evaluation of bioavailability of methylprednisolone succinate administered intravenously; Evaluation of bioavailability of methylprednisolone succinate administered intranasally
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: None (Open Label)
Primary purpose: Other
Keywords: methylprednisolone; intranasal; pharmacokinetics; Bioavailability