Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT01167894
Status:
COMPLETED
Last Update Posted:
2010-07-22
First Post:
2010-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting Condition
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study of Simvastatin 80 mg Tablets of Dr. Reddy's to be Compared With Zocor® 80 mg Tablets of Merck & Co. Inc., USA in Healthy Adult Subjects Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2010-07
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:
The purpose of this study is to
* compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fasting conditions
* monitor adverse events and to ensure the safety of subjects.
* compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co. Inc, USA in healthy subjects under fasting conditions
* monitor adverse events and to ensure the safety of subjects.
Detailed Description:
A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Simvastatin 80mg tablets of Dr. Reddy's Laboratories Limited to be compared with Zocor® 80 mg tablets of Merck \& Co. Inc., USA in healthy, adult, human subjects under fasting conditions.
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?: