Last updated: 11/04/2018 06:37:47
Azelastine bioequivalence study
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A pharmacokinetic study comparing two azelastine hydrochloride nasal formulations in a single dose design
Trial description: This bioequivalence study is designed to compare two azelastine hydrochloride nasal formulations. This trial has an adaptive design. A two stage sequential design approach has been adopted.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
AUC 0-t and Cmax plasma azelastine after single adminstration
Timeframe: 0-120 hours post dose on Day 1 Period I and Period II
Secondary outcomes:
Descriptive pharmacokinetic profile (e.g., AUC 0-t, AUC 0-infinity, Cmax and tmax)
Timeframe: 0-120 hours post dose on Day 1 Period I and Period II
Interventions:
Drug: Marketed azelastine hydrochloride nasal spray
Drug: Experimental azelastine hydrochloride nasay spray
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
azelastine hydrochloride
Collaborators
Not applicable
Study date(s)
August 2010 to April 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Year
Accepts healthy volunteers
yes
- Body Mass Index (BMI) between 18.5-30 kg/m2
- Vital signs: SBP 100-139 mmHg, DBP 50-89 mmHg, PR 50-90 bpm, measured after 5 min of rest (sitting position)
- Physical findings: clinically relevant abnormal physical examination findings which could interfere with the objectives of the study
- ECG (12 leads): clinically relevant abnormalities
Inclusion and exclusion criteria
Inclusion criteria:
- Body Mass Index (BMI) between 18.5-30 kg/m2
- Vital signs: SBP 100-139 mmHg, DBP 50-89 mmHg, PR 50-90 bpm, measured after 5 min of rest (sitting position)
- Contraception (females only): use of highly effective contraceptive methods for at least 1 month prior to the study start of the trial according to the definition of Note 3 of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some Intra-Uterine Devices (IUDs), sexual abstinence or vasectomised partner); or women of not child-bearing potential (i.e. permanently sterilized since at least 3 months) or in post-menopausal status for at least 1 year
- Contraception (males only): the male study participants should agree to use contraceptive for one week after the dosing
- Ability to cooperate with the Investigator and to comply with the requirements of the entire study
- Non-smokers -which means non-smoking since at least three months prior to the screening visit
Exclusion criteria:
- Physical findings: clinically relevant abnormal physical examination findings which could interfere with the objectives of the study
- ECG (12 leads): clinically relevant abnormalities
- Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness
- Virology: positive HBs Ag, HCV Ab and HIV 1/2 assays
- Allergy: ascertained or presumptive hypersensitivity to the active pharmaceutical ingredient and/or formulation excipients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- Diseases: clinically significant current or history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
- Current nasal abnormalities that may impact on the application or action of the investigational products, e.g. current perennial or seasonal allergic rhinitis, nasopharingitis, cold, or flu; Any clinically significant nasal anatomic abnormalities, such as severely deviated nasal septum, nasal polyps, completed blocked nostril, or history of nasal major surgeries
- Medications: Previous medication, including OTC (over-the-counter) and with the exception of oral contraceptives, within 14 days of the screening visit
- Investigative drug trials: participation in the evaluation of any investigational product within the following time period prior to the first dosing in the current study: 2 months or at least five half-lives of the previous investigational product, whichever is longer
- Blood donation: blood donations of any kind which exceeded 500mL of blood during the 3 months prior to study participation or if participation in this current study would cause a greater than 500ml blood loss over a period of 3 months
- Drug, alcohol, caffeine: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to USDA Dietary Guidelines 2005 (40) ] or caffeine (>5 cups coffee/tea/day). Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks
- Pregnancy: pregnant or lactating women
- Personnel: member or relative of the trial site staff or an employee of the Sponsor
- Participation: volunteers who already have taken part in the stage 1 of this study.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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