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NCT04235270 · ClinicalTrials.gov registry record · Phase 1
A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT04235270 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 62 participants.
The verdict
NCT04235270, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters of tadalafil administered as an fixed dose combination (FDC) (test) of macitentan/tadalafil (10 milligram \[mg\]/40 mg) and coadministered as a free combination (reference) of 10 mg macitentan (Opsumit) and 40 mg Canada-sourced tadalafil (Adcirca) in fasted conditions in healthy adult participants (Group 1) and to evaluate the effect of food on the primary PK parameters of macitentan and tadalafil administered as an FDC of macitentan/tadalafil (10 mg/40 mg) in healthy adult participants (Group 2).
Interventions
- DRUG Tadalafil
- DRUG Macitentan
- COMBINATION_PRODUCT FDC of Macitentan and Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-01-17 |
| Est. Completion | 2020-07-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04235270
The ClinicalTrials.gov registry entry for NCT04235270 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Tadalafil is the first listed.
NCT04235270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04235270 about?
NCT04235270 is a clinical study titled "A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants". The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters of tadalafil administered as an fixed dose combination (FDC) (test) of macitentan/tadalafil (10 milligram \[mg\]/40 mg) and coadministered as a free combination (reference) of 10 mg macitentan (...
What is the current status of trial NCT04235270?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2020-01-17. Estimated completion is 2020-07-17.
What interventions are being tested in trial NCT04235270?
The interventions under investigation include: Tadalafil (DRUG), Macitentan (DRUG), FDC of Macitentan and Tadalafil (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04235270?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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