Pooled Analysis of Individual Subjects' Data After Combining the Data From the Bioequivalence Studies Conducted for Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals (Test, T) vs ADVAIR DISKUS® 250/50 mcg Inhalation Powder/GSK (Reference, R)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Cmax
Overview
Brief Summary
A pooled analysis of three bioequivalence studies conducted for Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (Test, T) vs ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK (Reference, R) were conduted.
Detailed Description
Data from three Bioequivalence studies with study codes: BECRO/RESP/BREATH-BE250-PIVOTAL (BE250-PIVOTAL), BECRO/RESP/BREATH-BE250-PILOT (BE250-PILOT) and BECRO/RESP/BREATH-PK250 (PK250) were included.
A pooled analysis of all three studies was conducted, including all eighty-two (82) subjects of the three studies. Then, a pooled analysis of the BE250-PIVOTAL and the respective Pilot study (BE250-PILOT) was also conducted since these two studies used products of the same batch, including forty-eight (48) subjects.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
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 at reproductive age i.e.pre-menopausal or unable to gestate \[i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration\].
- •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
Test Product
Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals
Intervention: Test (Drug)
Reference Product
ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK
Intervention: Reference (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: up to 36 hours post-administration
Maximum plasma concentration, it is read directly from the raw data
AUC(0-t)
Time Frame: up to 36 hours post-administration
Area under the plasma concentration curve from time 0 to the last measured
Secondary Outcomes
No secondary outcomes reported