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NCT05433675
A Study of Two Macitentan Formulations in Healthy Adult Participants
Phase 1 trial testing Macitentan in Healthy in 28 participants. Completed in 3 October 2022.
31 August 2022
Quick facts
| Lead sponsor | Actelion |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 28 |
| Start date | 22 June 2022 |
| Primary completion | 31 August 2022 |
| Estimated completion | 3 October 2022 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Macitentan (MACITENTAN) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Actelion — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult participants in fasted 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 NCT05433675
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Macitentan
Trials testing the same drug.
- NCT05731492 — A Study of Macitentan in Children Below 2 Years of Age · Phase 1 · withdrawn
- NCT05167825 — A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension · Phase 3 · completed
- NCT05392530 — A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Particip · Phase 1 · completed
- NCT05373108 — Endothelin-1 and Cardiac Allograft Vasculopathy (CAV) · Phase 4 · completed
- NCT05179876 — A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no O · Phase 3 · recruiting
Other recruiting trials for Healthy
Currently open trials in the same condition.
- NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
- NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Actelion trials
Trials by the same sponsor.
- NCT05731492 — A Study of Macitentan in Children Below 2 Years of Age · Phase 1 · withdrawn
- NCT05427162 — A Study of Single and Multiple Doses of Different Formulations of a Prostacyclin Receptor Agonist · Phase 1 · completed
- NCT05392530 — A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Particip · Phase 1 · completed
- NCT05179876 — A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no O · Phase 3 · recruiting
- NCT05236231 — A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Ma · 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 NCT05433675 (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 Actelion
- Last refreshed: 30 March 2025
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/NCT05433675.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing