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Seasonal Allergic RhinitisPhase 1NCT06180083

Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray

A Phase 1 study testing Azelastine Hydrochloride/ Fluticasone propionate nasal spray and 'DYMISTA' NASAL SPRAY in people with Seasonal Allergic Rhinitis and Perennial Allergic Rhinitis, run by Humanis Saglık Anonim Sirketi at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Single dose (four sprays) bioequivalence study of Azelastine Hydrochloride/ Fluticasone Propionate 137 microgram/50 microgram Nasal Spray and 'DYMISTA' (Azelastine Hydrochloride/Fluticasone Propionate) Nasal Spray 137 microgram/50 microgram in healthy adult human subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Azelastine Hydrochloride/ Fluticasone propionate nasal spray and 'DYMISTA' NASAL SPRAY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteIndia
Study dates
24 Mar 2023to 5 Jul 2023
Phase
Phase 1
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: 18 to 45 years old, both inclusive.
  • Gender: Male and/or non-pregnant, non-lactating female.
  • Female of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first dosing day. They used an acceptable form of contraception.
  • For female of childbearing potential, acceptable forms of contraception included the following:
  • Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remained in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practiced sexual abstinence throughout the course of the study c)Female were not considered of childbearing potential in case one of the following was reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months.
  • BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value were rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
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  • No nasal abnormalities.
  • Non-smokers and non-tobacco users (i.e. had no past history of smoking and tobacco consuming for at least one year prior to study).
  • The subject was willing to undergo the necessary pre- \& post- medical examinations set by this study.
  • Was able to communicate effectively with study personnel.
  • Was able to understand and willing to provide written informed consent to participate in the study.
  • All volunteers were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which included:
  • A physical examination (clinical examination) with no clinically significant finding.
  • Results within normal limits or clinically non-significant for the following tests:
  • Hematology, Biochemistry, Urinalysis, Immunological Tests, Serum (β-HCG) pregnancy test (for female of child bearing potential)

Who cannot join

  • History of allergic responses to Azelastine and Fluticasone Propionate or other related drugs, or any of its formulation ingredients.
  • Had significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, nasal examination [examination include (1) external nose but not limited to size and shape, obvious swellings or deformity, scars or skin changes and redness or discharge and (2) nasal cavity for but not limited to nasal septum, turbinates, entire nasal cavity for rhinitis, oedematous and inflamed mucosa, polyps or any other abnormalities and presence of any foreign bodies], Peak Nasal Inspiratory Flow measurement, chest X-ray recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)].
  • Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
  • History or presence of bronchial asthma.
  • Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
  • A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
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  • Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
  • History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
  • History of difficulty with donating blood or difficulty in accessibility of veins.
  • A positive hepatitis screen (includes subtypes B \& C).
  • A positive test result for HIV antibody and / or syphilis (RPR).
  • Volunteers who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication or who had participated in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the first dose of study medication, whichever was greater.
  • Volunteers who had donated blood within 80 days (excluding volume drawn at screening for this study) prior to first dose of study medication.
  • Intolerance to venipuncture
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, contraindicated the volunteer's participation in this study.
  • Institutionalized volunteers.
  • Used any prescribed medications (including ritonavir, cobicistat \& CNS depressants) within 14 days prior to the first dose of study medication.
  • Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
  • Used grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
  • Ingested of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
  • Ingested any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
  • Volunteer had any illness since screening visit.
  • Volunteer had any relevant disease including seasonal and perennial allergic rhinitis, asthma during screening.
  • Volunteer had clinically relevant structural nasal abnormalities including deviated nasal septum, and upper respiratory tract infection within two weeks prior to the start of the study.
  • Volunteer took steroids or any antihistamines or any drug related to allergic medication within 1 month prior to the dose of study medication.
  • Volunteer who was not ready to remove Nasal jewelry prior to enrollment in the study
  • Presence of nose piercings, which affected spray inhalation dosing and increase the deposition of the study drug in the nose.
  • Presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis, or other eye infection

Trial locations and contacts

1 site in 1 country.

India1 site

  • Cliantha Research Limited

    Ahmedabad, Gujarat, 382210

Other trials in India

About this study

Official title: Single Dose Bioequivalence Study of Azelastine Hydrochloride/Fluticasone Propionate 137microgram/50 Microgram Nasal Spray and DYMISTA Nasal Spray in Healthy Adult Human Subjects

Single dose (four sprays) bioequivalence study of Azelastine Hydrochloride/ Fluticasone Propionate 137 microgram/50 microgram Nasal Spray and 'DYMISTA' (Azelastine Hydrochloride/Fluticasone Propionate) Nasal Spray 137 microgram/50 microgram in healthy adult human subjects.

Being tested
Azelastine Hydrochloride/ Fluticasone propionate nasal spray, 'DYMISTA' NASAL SPRAY
Medical subject headings
Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azelastine Hydrochloride/ Fluticasone propionate nasal sprayDrug

    A single dose [four sprays (two sprays in each nostril)] of Azelastine HCL/ Fluticasone Propionate 137 mcg/50 mcg Nasal Spray

  • 'DYMISTA' NASAL SPRAYDrug

    A single dose [four sprays (two sprays in each nostril)] of 'DYMISTA' (AZELASTINE HYDROCHLORIDE/ FLUTICASONE PROPIONATE) NASAL SPRAY 137 Microgram/50 Microgram

Study groups in NCT06180083
Study groupRoleWhat they receive
Azelastine Hydrochloride/ Fluticasone propionate nasal sprayExperimentalAzelastine Hydrochloride/ Fluticasone propionate 137 microgram/50 microgram nasal spray
Receives: Drug: Azelastine Hydrochloride/ Fluticasone propionate nasal spray; Drug: 'DYMISTA' NASAL SPRAY
'DYMISTA' Nasal SprayActive comparator'DYMISTA' (Azelastine Hydrochloride/ Fluticasone Propionate) Nasal Spray 137 microgram/50 microgram
Receives: Drug: Azelastine Hydrochloride/ Fluticasone propionate nasal spray; Drug: 'DYMISTA' NASAL SPRAY

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum measured plasma concentration(Cmax)

    The 90% confidence interval of the relative mean (geometric least square mean) of the test to reference product for Ln-transformed Pharmacokinetic parameters Cmax was to be within 80.00% to 125.00%

    Measured: 120 hours

  2. Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration (AUCt)

    The 90% confidence intervals of the relative mean (Geometric least square mean) of the test to reference formulation for Ln-transformed AUCt was to be within 80.00% to 125.00%.

    bioequivalence.

    Measured: 120 hours

Secondary outcomes (2)

  1. Area under the plasma concentration versus time curve from time zero to infinity (AUCi)

    Descriptive statistics

    Measured: 120 hours

  2. Time of the maximum measured plasma concentration (Tmax)

    Descriptive statistics

    Measured: 120 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2023
  2. Study start24 Mar 2023
  3. Primary completion26 Apr 2023
  4. Study completion5 Jul 2023

Resources

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06180083
Sponsor's protocol ID
C1B01728
Status last verified
Dec 2023
First submitted
9 Dec 2023
Last updated
28 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Azelastine Hydrochloride/ Fluticasone propionate nasal spray and 'DYMISTA' NASAL SPRAY in people with Seasonal Allergic Rhinitis and Perennial Allergic Rhinitis, run by Humanis Saglık Anonim Sirketi at 1 site in India.

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 15 inclusion and 28 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 28 Dec 2023. 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 India. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Maximum measured plasma concentration(Cmax) (time frame: 120 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06180083.

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 28 Dec 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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