Dexamethasone AdministrationNCT05647408
Evaluation of the Bioavailability of Dexamethasone in Healthy Subjects
A study testing Dexamethasone in people with Dexamethasone Administration and Intranasal Administration, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
The most important property of a dosage of a drug administration 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dexamethasone Administration, Intranasal Administration, Inflammation
- What is being tested?
- Dexamethasone
- 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 13 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
- Age: 18 - 35 years (inclusive)
- Health Status: Clinically healthy research subjects with the absence of clinically relevant abnormalities as identified by a medical history, physical examination, including determination of vital signs, a 12-lead electrocardiogram, and laboratory tests (which should be within normal values). allowed and corresponding validity, deviations will not be accepted)
- Have not consumed any medication 2 days before starting hospitalization.
- Signed and dated Informed Consent Form.
- Body mass index of 18 -27 Kg/m2.
- That it has been released from the COFEPRIS bioequivalence system database.
- Signed non-pregnancy commitment letter (by female subjects)
Who cannot join
- Subjects presenting any of the following circumstances will not be included in the study:
- Clinical evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease or severe allergic reactions.
- Any condition that may affect the absorption of the drug. (ex. Gastrectomy, Sprue, etc.)
- Positive urine test for substances of abuse. Positive pregnancy test.
- Use of products containing tobacco or nicotine 72 hours before and for the entire duration of the study.
- Smoker (No more than 1 cigarette per day) or who has difficulty abstaining from tobacco consumption 72 hours before and for the entire duration of the study.
Show all 20Show fewer
- History of frequent excessive alcohol consumption 7 drinks per week for female subjects or 14 drinks per week for male subjects (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 4 months prior to the canvass.
- Alcohol consumption before (48 hours) and during the study. (For this purpose, a breath test will be carried out with a breathalyzer prior to the start of each session).
- Consumption of food or beverages that contain grapefruit and/or grapes or citrus fruits related to grapefruit (citrus) as well as carbonated foods or vegetarian diet or chocolate or coffee, from 3 days before the start of the study and until the last sample has been obtained.
- Study drug treatment 30 days prior.
- History of hypersensitivity to the study drug or its derivatives.
- History of heparin sensitivity or heparin-induced thrombocytopenia.
- A 12-lead resting EKG demonstrating a QTc of >450 msec at the time of screening. If the QTc exceeds 450 msec, the test should be repeated twice and the average of the three tests relative to the QTc should be used to determine subject eligibility (in the presence of clinical pathology findings).
- Being participating in another study or having participated in another study without having elapsed at least the time equivalent to 7 half-lives of the drug administered in the previous study or without having elapsed 3 months. (whatever happens next)
- Presence of use of prescription or non-prescription medications, dietary supplements, pre-study or herbal supplements, and hormonal methods of contraception (including oral, transdermal, injectable contraceptives, injectable progesterone, progestin implants). Women are expected to take appropriate precautions to prevent pregnancy and fetal exposure to a potentially toxic agent for the duration of the study (from the screening visit to the end of the study). Women of childbearing age will be informed that they must take the appropriate measures to prevent pregnancy during the study, such as the following: a) Willing to maintain abstinence (not having sexual intercourse) from 14 days before the start of the study to 28 days after the start of the study. end of study or b) Be willing to use two effective methods of birth control (condom, diaphragm, cervical cap, vaginal sponge, spermicides, non-hormonal IUD, tubal ligation, partner with vasectomy). Either of the two options from 14 days before the start of the study and up to 28 days after its conclusion. In no case may a lactating female subject participate.
- Blood donation approximately 1 unit (500 mL) in a period of less than 90 days before the first study session.
- Inability or refusal to comply with the indications described in this protocol.
- Any other acute or chronic, medical or psychiatric, or laboratory condition that may increase the risk associated with the participation of the product to be administered or that may interfere with the interpretation of the study results and, in the Investigator's opinion, may compromise the participation of the subject in the study, including any type of recent hospitalization (1 month).
- Results outside the normal values for the hematological, biochemical and laboratory tests carried out in the selection phase.
- Subjects who have ingested a drug that induces or inhibits metabolism within the last two weeks prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Pilot Study to Evaluate the Bioavailability of Dexamethasone Administered Through Intranasal vs Intravenous Route.
The most important property of a dosage of a drug administration 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. Dexamethasone 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 dexamethasone 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 Absolute Bioavailability (for information purposes) of Dexamethasone 8 mg/2 ml Injectable Solution (Intranasal Route 6 mg/ 1.5 ml Vs Intravenous Route 6 mg/ 1.5 ml), according to the specific evaluation parameters and general under fasting conditions.
- Conditions
- Dexamethasone Administration, Intranasal Administration, Inflammation, Intravenous Drug Usage, Healthy Subjects
- Being tested
- Dexamethasone
- Keywords
- dexamethasone, intranasal, pharmacokinetics, Bioavailability
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
The nominal doses were similar, volunteers were randomly assigned to receive a single dose of DXM by IV bolus of 1.5 mL (equivalent to 6 mg of dexamethasone) or the same dose 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 DMX | Active comparator | Male and female volunteers received one dose of DXM. Drugs formulations employed were DXM phosphate injectable solution 8 mg/2 mL (Alin, Productos Farmaceuticos, Mexico). The drug was administered to 4 subjects intravenously (treatment A) according to a randomization list generated prior to the start of the clinical phase. Receives: Drug: Dexamethasone |
| Intranasally DMX | Active comparator | Male and female volunteers received one dose of either DXM Drugs formulations employed were DXM phosphate injectable solution 8 mg/2 mL (Alin, Productos Farmaceuticos, Mexico). The drug was administered to 4 healthy subjects intranasally (treatment B). According to a randomization list generated prior to the start of the clinical phase. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Bioavailability of Dexamethasone (6 mg/ 1.5 mL Intranasal Route vs. 6 mg/ 1.5 mL 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 Alin® 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 posted12 Dec 2022
- Study start5 Nov 2021
- Primary completion6 Nov 2021
- Study completion13 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexamethasone 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
- 2 PERIODS, 2 TREATMENTS, 2 SEQUENCES, CROSSOVER 2X2.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edda Sciutto Conde, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647408
- Sponsor's protocol ID
- BE20065-P
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 12 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 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Pilot Study to Evaluate the Bioavailability of Dexamethasone Administered Through Intranasal vs Intravenous Route.
- ClinicalTrials.gov ID
- NCT05647408
- Acronym / sponsor ID
- BE20065-P
- Conditions
- Dexamethasone Administration, Intranasal Administration, Inflammation, Intravenous Drug Usage, Healthy Subjects
- Keywords
- dexamethasone, intranasal, pharmacokinetics, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 6 Nov 2021 (actual)
- Study completion
- 13 Nov 2021 (actual)
- First posted
- 12 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.
The most important property of a dosage of a drug administration 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. Dexamethasone 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 dexamethasone 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 Absolute Bioavailability (for information purposes) of Dexamethasone 8 mg/2 ml Injectable Solution (Intranasal Route 6 mg/ 1.5 ml Vs Intravenous Route 6 mg/ 1.5 ml), according to the specific evaluation parameters and general under fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 PERIODS, 2 TREATMENTS, 2 SEQUENCES, CROSSOVER 2X2.
| Arm | Type | Receives |
|---|---|---|
| Intravenously DMX | Active comparator | Drug: DexamethasoneMale and female volunteers received one dose of DXM. Drugs formulations employed were DXM phosphate injectable solution 8 mg/2 mL (Alin, Productos Farmaceuticos, Mexico). The drug was administered to 4 subjects intravenously (treatment A) according to a randomization list generated prior to the start of the clinical phase. |
| Intranasally DMX | Active comparator | Drug: DexamethasoneMale and female volunteers received one dose of either DXM Drugs formulations employed were DXM phosphate injectable solution 8 mg/2 mL (Alin, Productos Farmaceuticos, Mexico). The drug was administered to 4 healthy subjects intranasally (treatment B). According to a randomization list generated prior to the start of the clinical phase. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
- Age: 18 - 35 years (inclusive)
- Health Status: Clinically healthy research subjects with the absence of clinically relevant abnormalities as identified by a medical history, physical examination, including determination of vital signs, a 12-lead electrocardiogram, and laboratory tests (which should be within normal values). allowed and corresponding validity, deviations will not be accepted)
- Have not consumed any medication 2 days before starting hospitalization.
- Signed and dated Informed Consent Form.
Key exclusion criteria (20 listed)
- Clinical evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease or severe allergic reactions.
- Any condition that may affect the absorption of the drug. (ex. Gastrectomy, Sprue, etc.)
- Positive urine test for substances of abuse. Positive pregnancy test.
- Use of products containing tobacco or nicotine 72 hours before and for the entire duration of the study.
- Smoker (No more than 1 cigarette per day) or who has difficulty abstaining from tobacco consumption 72 hours before and for the entire duration of the study.
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 |
|---|---|---|
| DexamethasoneThe nominal doses were similar, volunteers were randomly assigned to receive a single dose of DXM by IV bolus of 1.5 mL (equivalent to 6 mg of dexamethasone) or the same dose 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 DMX, Intravenously DMX |
Primary outcome
Absolute Bioavailability of Dexamethasone (6 mg/ 1.5 mL Intranasal Route vs. 6 mg/ 1.5 mL 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 Alin® 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 12 Dec 2022.
- Individual participant dataSharing planned: No
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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 Dexamethasone in people with Dexamethasone Administration and Intranasal Administration, run by Universidad Nacional Autonoma de Mexico 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 8 inclusion and 20 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 12 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 Dexamethasone (6 mg/ 1.5 mL Intranasal Route vs. 6 mg/ 1.5 mL 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 12 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.