Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553937
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg40 Mg and PrOpsynvi Macitentan and Tadalafil Film-coated Tablets 10 Mg40 Mg
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single Dose Oral Bioequivalence Study of Macitentan and Tadalafil Filmcoated Tablets 10 Mg40 Mg and PrOpsynvi Macitentan and Tadalafil Film-coated Tablets 10 Mg40 Mg in Healthy Adult Male Subjects Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg40 mg and PrOpsynvi Macitentan and Tadalafil film-coated tablets 10 mg40 mg in healthy adult male subjects under fed conditions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None