Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT02322658
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2014-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
An Open Label, Balanced, Randomized, Two-Treatment, Two Period, Two-Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Eszopiclone Tablets 3 mg of Dr. Reddy's Laboratories Limited, and 'LUNESTA' Tablets 3 mg, Mfg For Sepracor Inc. USA In Healthy Adult Human Subjects Under Fed Conditions.
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:
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
Detailed Description:
An open label, balanced, randomized, two-treatment, two-period, two-sequence,single dose, crossover, oral bioequivalence study of Eszopiclone tablets 3 mg of Dr. Reddy's Laboratories limited, and 'LUNESTA' tablets 3 mg Mfg for Sepracor Inc. USA in healthy adult human subjects 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?: