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NCT03820180
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 trial testing Test Product in Bioequivalence in 34 participants. Completed in 19 February 2019.
12 February 2019
Quick facts
| Lead sponsor | Respirent Pharmaceuticals Co Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 34 |
| Start date | 23 January 2019 |
| Primary completion | 12 February 2019 |
| Estimated completion | 19 February 2019 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Test Product — full drug profile →
- Reference Product — full drug profile →
Conditions studied
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
Respirent Pharmaceuticals Co Ltd. — full company profile →
Who can join
Adults 18 to 60, any sex, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03820180
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Test Product
Trials testing the same drug.
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- NCT05372900 — Nutritional Intervention to Improve Sleep Quality and Improve Next-day Mood and Cognitive Benefits · NA · completed
- NCT04466176 — A Pivotal Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/ · Phase 1 · completed
- NCT03975166 — A Bioequivalence Study Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respiren · Phase 1 · completed
- NCT04051710 — Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH · Phase 3 · completed
Other recruiting trials for Bioequivalence
Currently open trials in the same condition.
- NCT07096869 — Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Pa · Phase 1 · recruiting
Other Respirent Pharmaceuticals Co Ltd. trials
Trials by the same sponsor.
- NCT06025214 — Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunte · Phase 1 · unknown
- NCT05982990 — Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunte · Phase 1 · unknown
- NCT05697003 — Bioequivalence Study for Fluticasone Propionate 100 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunte · Phase 1 · unknown
- NCT05664061 — Bioequivalence With Clinical Endpoint Study of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Re · Phase 3 · unknown
- NCT05397834 — A Bioequivalence Study Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals v · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03820180 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Respirent Pharmaceuticals Co Ltd.
- Last refreshed: 27 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03820180.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing