Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04540744
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2020-09-02
Brief Title:
A Study of MacitentanTadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Single-center Open-label Single-dose Randomized 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Relative Oral Bioavailability of the Combination of MacitentanTadalafil 10 mg20 mg Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of 10 mg Macitentan Opsumit and 20 mg Tadalafil Adcirca
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the rate and extent of absorption of macitentan and tadalafil following administration of a single oral dose of a fixed-dose combination FDC of 10 milligram mg20 mg macitentantadalafil test compared to the coadministration as a free combination reference of 10 mg macitentan and 20 mg tadalafil under fasted conditions in healthy adult participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 67896062PAH1001 | OTHER | Janssen Research Development LLC | None |
| 2020-000566-42 | EUDRACT_NUMBER | None | None |