Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02476864
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2015-06-11
Brief Title:
Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Single-center Open-label Randomized Two-treatment Single-dose Crossover Study in Healthy Subjects to Investigate the Biocomparison of the Adult and Pediatric Formulation of Macitentan
Status:
COMPLETED
Status Verified Date:
2016-04
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:
A study conducted in healthy adults to investigate if a new macitentan tablet leads to the same fate of macitentan in the body time of onset time of presence amount in the blood as the marketed macitentan tablet
Detailed Description:
The purpose of this study is to establish biocomparison of 2 types of tablets containing macitentan a pediatric dispersible tablet and the adult film-coated tablet A single oral dose of each tablet will be given to healthy subjects on 2 different periods separated by a washout phase of 10 to 14 days
Biocomparison will be based on the comparison of the pharmacokinetic parameters of macitentan with the two types of tablets using specific statistical methods The pharmacokinetic parameters will be considered equivalent if specific criteria defined in the study protocol are met
Biocomparison will be based on the comparison of the pharmacokinetic parameters of macitentan with the two types of tablets using specific statistical methods The pharmacokinetic parameters will be considered equivalent if specific criteria defined in the study protocol are met
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001623-23 | EUDRACT_NUMBER | None | None |