Trials / Completed
CompletedNCT05196399
Bioequivalence Study of Different Aprocitentan Tablet Formulations
A Single-center, Open-label, Randomized, Two-way Crossover Phase 1 Study to Compare the Single-dose Pharmacokinetics of Different Tablet Formulations of Aprocitentan in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Idorsia Pharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aprocitentan (Formulation A) | A single oral dose of 25 mg. |
| DRUG | Aprocitentan (Formulation B) | A single oral dose of 25 mg. |
Timeline
- Start date
- 2022-02-02
- Primary completion
- 2022-03-27
- Completion
- 2022-04-07
- First posted
- 2022-01-19
- Last updated
- 2022-11-23
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT05196399. Inclusion in this directory is not an endorsement.