Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05236231 · ClinicalTrials.gov registry record · Phase 1
A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants
A Phase 1 study of Healthy, sponsored by Actelion.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05236231: Completed Phase 1 study of Healthy, sponsored by Actelion.
NCT05236231 is a Phase 1 study of Healthy that has completed, run by Actelion. The registered enrollment target is 40 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05236231, a Phase 1 study of Healthy, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters between macitentan and tadalafil administered as a fixed dose combination (FDC) (test) of macitentan/tadalafil and the co- administered free combination (reference) of macitentan (Opsumit) and tadalafil (Adcirca) in fasted conditions in healthy adult participants; and to evaluate the effect of food on the primary PK parameters of macitentan and tadalafil administered as an FDC of macitentan/tadalafil in fed versus fasted conditions in healthy adult participants.
Primary Outcome
Cmax is defined as the maximum observed plasma analyte concentration.
Conditions Studied
Interventions
- DRUG Macitentan 10 mg
- DRUG Tadalafil 20 mg
- DRUG Macitentan 10 mg/Tadalafil 20mg FDC
Study Locations (1)
Utah
- PRAHS - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-02-04 |
| Est. Completion | 2022-05-14 |
| Phase | Phase 1 |
What the finished NCT05236231 record still lists
NCT05236231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Macitentan 10 mg is the first listed.
NCT05236231 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT05236231 about?
NCT05236231 is a clinical study titled "A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants". The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters between macitentan and tadalafil administered as a fixed dose combination (FDC) (test) of macitentan/tadalafil and the co- administered free combination (reference) of macitentan (Opsumit) and t...
What is the current status of trial NCT05236231?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-02-04. Estimated completion is 2022-05-14.
What conditions does trial NCT05236231 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05236231?
The interventions under investigation include: Macitentan 10 mg (DRUG), Tadalafil 20 mg (DRUG), Macitentan 10 mg/Tadalafil 20mg FDC (DRUG).
Who is sponsoring clinical trial NCT05236231?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05236231 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05236231's enrollment target sits among peer trials
40 540th of 1090 higher than 513 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
RECRUITING · Phase 1
-
A Study of LY3867070 in Healthy Participants
RECRUITING · Phase 1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
RECRUITING · Phase 1
-
Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
RECRUITING · Phase 1
-
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
RECRUITING · Phase 1
-
A Study of V118E in Healthy Participants (V118E-003)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI