Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT01159158
Status:
COMPLETED
Last Update Posted:
2010-07-13
First Post:
2010-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
RANDOMIZED, 2-WAY CROSSOVER, BIOEQUIVALENCE STUDY OF NATEGLINIDE 120 mg TABLET AND STARLIX@ ADMINISTERED AS 1 x 120 mg TABLET IN HEALTHY SUBJECTS UNDER FASTING CONDITIONS
Status:
COMPLETED
Status Verified Date:
2007-01
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 objective of this study is to compare the rate and extent of absorption of nateglinide 120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under fasting conditions.
Detailed Description:
Single center, bioequivalence, open-label, randomized, 2-way crossover study. 64 + 4 healthy adult male or female, smokers and/or non-smokers. Single oral dose (1 x 120 mg) in each period with a washout of at least 7 days between doses. Dosing with 240 ml of glucose solution (25%).
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?: