NCT05982990
Active, not recruiting
Phase 1
A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Respirent Pharmaceuticals Co Ltd.1 site in 1 country34 target enrollmentStarted: August 1, 2023Last updated:
ConditionsBioequivalence
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Cmax for Salmeterol
Overview
Brief Summary
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Detailed Description
A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 250 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
laboratory-blinded
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers of both genders, aged ≥18 and ≤60 years.
- •Subjects with Body Mass Index (ΒΜΙ) ≥18.5 and \<30.0 kg/m
- •Healthy volunteers are declared healthy based on medical history, physical examination, ECG, pulmonary function test (a forced expiratory volume in 1 second (FEV1) ≥80% of the predicted normal value), and clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator.
- •Females who participate in the study are either unable to gestate \[i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration\] or at reproductive age; Females of reproductive age if sexually active, must be practicing an effective method of birth control within 14 days prior to the first drug administration and throughout the study.
- •Reliable contraception methods are considered the following:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal progestogen-only hormonal contraception associated with inhibition of ovulation oral, implantable or injectable intrauterine device (IUD) intrauterine hormone-releasing system (IUS) bilateral tubal occlusion vasectomised partner sexual abstinence
- •Subjects that are non-smokers
- •Subjects that, in the opinion of the principal investigator/medical officer, are able to communicate and comply with the study procedures and protocol restrictions as evidenced by the Informed Consent Form (ICF) duly read, signed and dated by the subject prior to study initiation.
- •Subjects able to use the inhalers according to given instructions, as judged by the Investigator or study nurse
Exclusion Criteria
- •Hypersensitivity to the active substance(s) or to the excipient (lactose which contains small amounts of milk protein may cause allergic reactions) or related class (any sympathomimetic drug or any inhaled, intranasal, or systemic corticosteroid therapy) of the medicinal product
- •Clinically significant illness or surgery within four weeks prior to dosing.
- •Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure \<90 or \>140 mmHg, seated diastolic blood pressure \<50 or \>90 mmHg or heart rate less than 50 or over 100 bpm) at screening.
- •Clinically significant history or presence of chronic bronchitis, emphysema,asthma or any other lung disease.
- •History or presence of pulmonary tuberculosis.
- •Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit.
- •History or presence of significant cardiovascular, endocrinal, neurologic, immunological, psychiatric or metabolic disease.
- •History of significant alcohol or drug abuse within one year prior to the screening visit.
- •Regular use of alcohol within six months prior to screening visit (more than 14 alcohol units per week) \[1Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol\].
- •Inability to abstain from alcohol for the duration of study period.
Arms & Interventions
Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals
Experimental
Test
Intervention: Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals (Drug)
ADVAIR DISKUS® 250/50
Active Comparator
Reference
Intervention: ADVAIR DISKUS® 250/50 (Drug)
Outcomes
Primary Outcomes
Cmax for Salmeterol
Time Frame: up to 36 hours post-administration
Maximum plasma concentration, it is read directly from the raw data
Cmax for Fluticasone Propionate (FP)
Time Frame: up to 36 hours post-administration
Maximum plasma concentration, it is read directly from the raw data
(AUC0-t) for Fluticasone Propionate (FP)
Time Frame: up to 36 hours post-administration
Area under the plasma concentration curve from time 0 to the last measured
AUC0-t for Salmeterol
Time Frame: up to 36 hours post-administration
Area under the plasma concentration curve from time 0 to the last measured
Secondary Outcomes
- AUC0-∞(up to 36 hours post-administration)
- Tmax(up to 36 hours post-administration)
- λz(up to 36 hours post-administration)
- Residual Area(up to 36 hours post-administration)
- t1/2(up to 36 hours post-administration)
Investigators
Study Sites (1)
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