Ignite Creation Date:
2025-12-18 @ 9:17 AM
Ignite Modification Date:
2025-12-23 @ 9:48 PM
Study NCT ID:
NCT02283840
Status:
None
Last Update Posted:
2014-12-10 00:00:00
First Post:
2014-11-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation
Sponsor:
None
Organization:
Study Overview
Official Title:
Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate 400mg, 600mg and 800mg Tablets Clinical Trial Formulation (CTF) Versus the To-be-marketed Formulation (TBM) in Healthy Male and Female
Status:
None
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 center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design to evaluate and compare the relative bioavailability and therefore the bioequivalence of three doses (400 mg, 600 mg and 800 mg) of eslicarbazepine acetate for two formulations (CTF versus TBM) after a single oral dose administration under fasting 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?: