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NCT04564456
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 trial testing Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent in Bioequivalence in 34 participants. Completed in 31 December 2020.
31 October 2020
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 | 22 September 2020 |
| Primary completion | 31 October 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent — full drug profile →
- ADVAIR DISKUS® 500/50 — 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
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Packaging and Delivery of Asthma Therapeutics.
Mathis BJ, Kusumoto M, Zaboronok A, Hiramatsu Y. · · 2021 · cited 9× · PMID 35056988 · DOI 10.3390/pharmaceutics14010092
Verify or expand the search:
- PubMed search for NCT04564456
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent
Trials testing the same drug.
- NCT04546256 — A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Re · Phase 1 · 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 NCT04564456 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 20 January 2021
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/NCT04564456.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing