Trial · NCT07891780
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
NCT07891780, Phase 2, Not yet recruiting, Hikma Pharmaceuticals USA Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients. Trials, record NCT07891780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07891780
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
- NCT number
- NCT07891780
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Hikma Pharmaceuticals USA Inc.
- Conditions
- Epinephrine, Hypersensitivity, Immediate, Anaphylaxis
- Interventions
- Epinephrine Nasal Spray, 2.5 mg, Epinephrine Nasal Spray, 5.25 mg
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the PK of a single dose of ENS in children and adolescents (2-17 years) | 0-240 minutes | Epinephrine Maximal concentration (Cmax) |
| Primary | To assess the PK of a single dose of ENS in children and adolescents (2-17 years) | 0-240 minutes | Time at maximal concentration (Tmax) |
| Primary | To assess the PK of a single dose of ENS in children and adolescents (2-17 years) | 0-240 minutes | Area under the curve 0-240 min. (AUC0-240) based on observed plasma concentration-time data |
| Secondary | To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years) | until 240 minutes post-dose | Maximum effect (Emax) for Systolic blood pressure (SBP) until 240 min. post-dose. |
| Secondary | To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years) | until 240 minutes post-dose | Maximum effect (Emax) for Diastolic blood pressure (DBP) until 240 min. post-dose. |
| Secondary | To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years) | until 240 minutes post-dose | Maximum effect (Emax) for Pulse rate (PR) until 240 min. post-dose. |
| Secondary | To evaluate the PD of a single dose of ENS in children and adolescents (2-17 years) | until 240 minutes post-dose | Maximum effect (Emax) for Mean Arterial Pressure (MAP) until 240 min. post-dose. |
| Secondary | Occurrence of Treatment-emergent Adverse Events (TEAE) [Safety and Tolerability] | 15 days | Occurrence of Treatment-emergent Adverse Events (TEAE) until Day 15, after a single dose of ENS in children and adolescents (2-17 years) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07891780
GET https://conductscience.org/api/trials/v1/NCT07891780/registered