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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05236231
The ClinicalTrials.gov registry entry for NCT05236231 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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