Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-26 @ 10:22 AM
Study NCT ID:
NCT01923259
Status:
COMPLETED
Last Update Posted:
2013-08-15
First Post:
2013-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fed Condition
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
Single Dose Crossover Comparative Bioavailability Study of Donepezil 23 mg Tablets in Healthy Male and Female Volunteers / Fed State
Status:
COMPLETED
Status Verified Date:
2011-02
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:
To evaluate and compare the relative bioavailability and therefore the bioequivalence of two different formulations of donepezil after a single oral dose administration under fed conditions.
Detailed Description:
Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover study under fed conditions.
Study Oversight
Has Oversight DMC:
True
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?: