Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:25 PM
Study NCT ID:
NCT01164761
Status:
COMPLETED
Last Update Posted:
2010-07-19
First Post:
2010-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting Conditions
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
A Two-way Open Label Crossover Experimental Evaluation of Relative Bioavailabilities of Ramipril 10 mg Capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg Capsules of King Pharmaceuticals in Healthy Adult Human Male 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 characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under fasting conditions and to assess the bioequivalence.
* To monitor the safety of the subjects.
* To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under fasting conditions and to assess the bioequivalence.
* To monitor the safety of the subjects.
Detailed Description:
A Two-way open label crossover experimental evaluation of relative bioavailabilities of Ramipril 10 mg capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg capsules of King Pharmaceuticals in healthy adult human male subjects under fasting 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?: