Study to Compare the Pharmacokinetics of Fixed-Dose Combi... | NCT05887843

ID	Type	Description	Link
2023-000362-34	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride	Experimental	Drug: Mometasone + Azelastine Drug: Mometasone Furoate Drug: Azelastine Hydrochloride
Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine	Experimental	Drug: Mometasone + Azelastine Drug: Mometasone Furoate Drug: Azelastine Hydrochloride
Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate	Experimental	Drug: Mometasone + Azelastine Drug: Mometasone Furoate Drug: Azelastine Hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mometasone + Azelastine	Drug	Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril	Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCt	The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear up/log down variant of the trapezoidal method.	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
AUCinf	The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Ct/Kel, where Ct is the last measurable analyte concentration.	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Cmax	Maximum measured analyte concentration over the sampling period.	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Tmax	Time of the maximum measured analyte concentration over the sampling period.	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Kel	The apparent first-order elimination rate constant	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Thalf	The apparent elimination half-life	From time 0 hours (prior to dosing), up to 48 or 72 hours post dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis.
Willing to use acceptable, effective methods of contraception.
Be informed of the nature of the study and give written consent (adults) / assent and consent by legal guardian(s)/parent(s) (adolescents) prior to any study procedure.

Exclusion Criteria:

Known history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
Known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity.
Unable to tolerate direct venipuncture.
Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
Positive test result for urine drugs of abuse or urine cotinine.
Presence of nostril or septum piercing.
Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
Females who are pregnant, breast-feeding, or have used hormonal contraceptives within 21 days (oral and transdermal) or 6 months (implanted, injected, intravaginal, or intrauterine) prior to drug administration.
Donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 mL).
Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
Received any type of live vaccine within 30 days prior to drug administration.
Use of medication within 30 days prior to drug administration.
On a special diet within 30 days prior to drug administration.
Have had a tattoo or body piercing within 30 days prior to drug administration.

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Term
D000068656	Mometasone Furoate
C020976	azelastine