Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-11 @ 5:44 PM
Study NCT ID:
NCT03121820
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2017-04-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
Sponsor:
Geropharm
Organization:
Study Overview
Official Title:
A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg Tablets Versus Akatinol Memantine® (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg Tablets in Normal Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-07
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:
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects
Detailed Description:
Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: