A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- First Posted Date
- 2020-09-25
- Last Posted Date
- 2021-01-20
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 34
- Registration Number
- NCT04564456
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- First Posted Date
- 2020-09-11
- Last Posted Date
- 2021-03-09
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 14
- Registration Number
- NCT04546256
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Pivotal Bioequivalence Study 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
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- Drug: Test ProductDrug: Reference Product
- First Posted Date
- 2020-07-10
- Last Posted Date
- 2021-03-09
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 34
- Registration Number
- NCT04466176
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Pilot Bioequivalence Study 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
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- First Posted Date
- 2020-07-08
- Last Posted Date
- 2021-01-20
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 14
- Registration Number
- NCT04462822
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- Drug: Reference Product (SERETIDE DISKUS® 100/50 inhalation powder/GSK)Drug: Test Product (Fluticasone propionate and salmeterol xinafoate inhalation powder/Respirent Pharmaceuticals)Other: Activated Charcoal suspension
- First Posted Date
- 2019-10-11
- Last Posted Date
- 2020-07-07
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 36
- Registration Number
- NCT04124094
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Bioequivalence Study Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- Drug: Test ProductDrug: Reference Product
- First Posted Date
- 2019-06-05
- Last Posted Date
- 2019-09-10
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 34
- Registration Number
- NCT03975166
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade (BREATH-PK250-CC)
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- Drug: SERETIDE DISKUS® 250/50 inhalation powder/GSKOther: Activated Charcoal suspension
- First Posted Date
- 2019-03-28
- Last Posted Date
- 2019-06-05
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 36
- Registration Number
- NCT03894280
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Bioequivalence Study 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
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- Drug: Test ProductDrug: Reference Product
- First Posted Date
- 2019-01-29
- Last Posted Date
- 2019-03-27
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 34
- Registration Number
- NCT03820180
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. ADVAIR DISKUS® in Healthy Volunteers
Phase 1
Completed
- Conditions
- Bioequivalence
- Interventions
- First Posted Date
- 2018-11-23
- Last Posted Date
- 2018-12-28
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 34
- Registration Number
- NCT03751202
- Locations
- 🇬🇷
BECRO Clinical Facility, Larissa, Thessaly, Greece
A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma
Phase 3
Completed
- Conditions
- Asthma
- Interventions
- First Posted Date
- 2018-09-18
- Last Posted Date
- 2020-07-07
- Lead Sponsor
- Respirent Pharmaceuticals Co Ltd.
- Target Recruit Count
- 451
- Registration Number
- NCT03676413
- Locations
- 🇬🇷
BECRO Ltd., Athens, Greece
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