Methylprednisone AdministrationNCT05649878
Evaluation of the Bioavailability of Methylprednisolone
A study testing Evaluation of bioavailability of methylprednisolone succinate administered intravenously and Evaluation of bioavailability of methylprednisolone succinate administered intranasally in people with Methylprednisone Administration and Intranasal Administration, run by Edda Sciutto Conde at 1 site in Mexico.
Trial summary
This study is aimed to evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Methylprednisone Administration, Intranasal Administration, Intravenous Administration
- What is being tested?
- Evaluation of bioavailability of methylprednisolone succinate administered intravenously and Evaluation of bioavailability of methylprednisolone succinate administered intranasally
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteMexico
- Study dates
- 5 Nov 2021to 12 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally
This study is aimed to evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous
Read the 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
- Being tested
- Evaluation of bioavailability of methylprednisolone succinate administered intravenously, Evaluation of bioavailability of methylprednisolone succinate administered intranasally
- Keywords
- methylprednisolone, intranasal, pharmacokinetics, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of bioavailability of methylprednisolone succinate administered intravenouslyDrug
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.
Evaluation of bioavailability of methylprednisolone succinate administered intranasallyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Evaluation of bioavailability of methylprednisolone succinate administered intranasally |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start5 Nov 2021
- Primary completion10 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methylprednisone AdministrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edda Sciutto Conde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edda Sciutto Conde, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649878
- Sponsor's protocol ID
- BE-PNO-049-F01
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally
- ClinicalTrials.gov ID
- NCT05649878
- Acronym / sponsor ID
- BE-PNO-049-F01
- Conditions
- Methylprednisone Administration, Intranasal Administration, Intravenous Administration, Healthy Subjects
- Keywords
- methylprednisolone, intranasal, pharmacokinetics, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Edda Sciutto CondeUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenously MEP | Active comparator | Drug: Evaluation of bioavailability of methylprednisolone succinate administered intravenouslySingle 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. |
| Intranasally MEP | Active comparator | Drug: Evaluation of bioavailability of methylprednisolone succinate administered intranasallyVolunteers 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of bioavailability of methylprednisolone succinate administered intravenouslyBioavailability 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. | Drug | Intravenously MEP |
| Evaluation of bioavailability of methylprednisolone succinate administered intranasallyBioavailability 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. | Drug | Intranasally MEP |
Primary outcome
Absolute Bioavailability of Methylprednisolone, Intranasal Route vs. Intravenous Route
Time frame: 2 weeks
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of bioavailability of methylprednisolone succinate administered intravenously and Evaluation of bioavailability of methylprednisolone succinate administered intranasally in people with Methylprednisone Administration and Intranasal Administration, run by Edda Sciutto Conde at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Bioavailability of Methylprednisolone, Intranasal Route vs. Intravenous Route (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.