Last reviewed · How we verify
NCT06553924
Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg
Phase 1 trial testing Macitentan and Tadalafil film-coated tablets in PAH in 30 participants. Completed in 8 August 2024.
31 May 2024
Quick facts
| Lead sponsor | Humanis Saglık Anonim Sirketi |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 14 May 2024 |
| Primary completion | 31 May 2024 |
| Estimated completion | 8 August 2024 |
| Sites | 1 location across India |
Drugs / interventions tested
- Macitentan and Tadalafil film-coated tablets — full drug profile →
- PrOpsynvi® macitentan and tadalafil film-coated tablets — full drug profile →
Conditions studied
- PAH — all drugs for PAH →
Sponsor
Humanis Saglık Anonim Sirketi — full company profile →
Who can join
Adults 18 to 55, any sex, with PAH. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fasting conditions.
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 NCT06553924
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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- NCT07266779 — Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Pr · Phase 1 · completed
- NCT07266766 — Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tabl · Phase 1 · completed
- NCT07266792 — Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpipraz · Phase 1 · completed
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 NCT06553924 (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 Humanis Saglık Anonim Sirketi
- Last refreshed: 14 August 2024
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/NCT06553924.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing