To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed
This study has been completed.
Information provided by:
First received: April 16, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and Fed.
Drug: Lisinopril 40 mg Tablet (Zestril) under fed conditions.
Drug: Lisinopril 40 mg Tablet under fasting conditions.
Drug: Lisinopril 40 mg Tablet under fed conditions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized, 3-Way Crossover, Bioequivalence Study of Eon Labs Manufacturing Inc. (USA) and Zeneca (USA) (Zestril) 40 mg Lisinopril Tablet Administered as a 1 x 40 mg Tablet in Health Adult Males Under Fasting Conditions Under Fasting and Fed Conditions.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sandoz:
Primary Outcome Measures:
- Bioequivalence based on AUC and Cmax [ Time Frame: 50 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2000|
|Study Completion Date:||June 2000|
|Primary Completion Date:||June 2000 (Final data collection date for primary outcome measure)|
Lisinopril 40 mg Tablet under fed conditions.
|Drug: Lisinopril 40 mg Tablet under fed conditions.|
Active Comparator: 2
Lisinopril 40 mg Tablet (Zestril)
|Drug: Lisinopril 40 mg Tablet (Zestril) under fed conditions.|
Lisinopril 40 mg Tablet under fasting conditions.
|Drug: Lisinopril 40 mg Tablet under fasting conditions.|
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