Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02745860
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2016-04-18
Brief Title:
Comparison of Two Dose Strengths of Selexipag in Healthy Adults
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Single-center Open-label Randomized Two-way Crossover Study in Healthy Adult Male Subjects to Compare the Pharmacokinetics of Selexipag ACT-293987 Following Single Oral Administration of 4 Film-coated Pediatric Tablets of 50 µg vs One Film-coated Tablet of 200 µg Selexipag
Status:
COMPLETED
Status Verified Date:
2016-07
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:
Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children
Detailed Description:
Healthy male adults receive a single dose of selexipag 200 µg but using a different tablet strength 4 film-coated pediatric tablets of 50 µg versus one film-coated tablet of 200 µg selexipag during each of the two study periods There is a washout of 7-9 days between the two study treatment administrations
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