Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-04-13 @ 11:08 PM
Study NCT ID:
NCT02283827
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2014-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
Phase I, Open-label Drug Interaction Study Between Eslicarbazepine Acetate 1200mg and Phenytoin 300 mg Following Multiple Dose Administrations in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2014-12
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:
Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design
Detailed Description:
Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design:
Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases;
Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases
Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases;
Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases
Study Oversight
Has Oversight DMC:
False
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?: