Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
Completed
Abbott
Phase 4
2004-01-01
The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is
superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive
subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy
Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
Completed
Mylan Pharmaceuticals
Phase 1
2004-05-01
The objective of this study was to investigate the bioequivalence of Mylan amlodipine and
benazepril HCl 10 mg/20 mg to Novartis Lotrel® 10 mg/20 mg combination capsules following a
single, oral 10 mg/20 mg (1 x 10 mg/20 mg) dose administered under fed conditions.
Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
Completed
Mylan Pharmaceuticals
Phase 1
2004-05-01
The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and
benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a
single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.
Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions
Completed
Teva Pharmaceuticals USA
Phase 1
2004-04-01
The objective of this study is to compare the rate and extent of absorption of
amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered
as 1 x 10 mg capsule under fasting conditions.
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