Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03215966
Status:
COMPLETED
Last Update Posted:
2017-11-09
First Post:
2017-07-11
Brief Title:
A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Single-center Open-label Single-dose Two-period Randomized Crossover Phase I Study to Demonstrate Bioequivalence Between a Fixed Dose Combination Product Formulation of MacitentanTadalafil 10 mg40 mg and the Free Combination of 10 mg Macitentan Opsumit and 40 mg Tadalafil Adcirca in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2017-11
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 primary objective of this study is to demonstrate that macitentan and tadalafil administered as a fixed combination is bioequivalent to both compounds given as separate tablets given at the same doses as in the fixed combination ie whether the amounts of macitentan and tadalfil which reach the blood are comparable
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None