Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 5:58 AM
Study NCT ID:
NCT01146106
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2010-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2010-06
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 a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.
Detailed Description:
Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers.
A total of 43 non-smoking subjects (31 men and 12 women) were included in this study, of which 43 finished the study according to the protocol.The study was performed as a single-dose two-way (80 mg), crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test
A total of 43 non-smoking subjects (31 men and 12 women) were included in this study, of which 43 finished the study according to the protocol.The study was performed as a single-dose two-way (80 mg), crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test
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?: