To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed
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|ClinicalTrials.gov Identifier: NCT00883506|
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||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.||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2000|
|Actual Primary Completion Date :||June 2000|
|Actual Study Completion Date :||June 2000|
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.
- Bioequivalence based on AUC and Cmax [ Time Frame: 50 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883506
|Principal Investigator:||Eric Masson, Pharm.D.||Anapharm|