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NCT05397834
A Bioequivalence Study Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions
Phase 1 trial testing Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals in Asthma in 36 participants. Status unknown.
21 June 2022
Quick facts
| Lead sponsor | Respirent Pharmaceuticals Co Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 11 May 2022 |
| Primary completion | 21 June 2022 |
| Estimated completion | 1 September 2022 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals — full drug profile →
- FLOVENT DISKUS — full drug profile →
Conditions studied
- Asthma — all drugs for Asthma →
- Bioequivalence — all drugs for Bioequivalence →
Sponsor
Respirent Pharmaceuticals Co Ltd. — full company profile →
Who can join
Adults 18 to 60, any sex, with Asthma or Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05397834
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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
- NCT05085587 — Bioequivalence Study of Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharm · 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 NCT05397834 (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: 31 May 2022
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/NCT05397834.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing