The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fed conditions.
An open-label randomized, single dose, two way crossover oral bioequivalence study to compare Amlodipine Besylate/Benazepril Hydrochloride 10 mg/40 mg capsules (Dr. Reddy's Laboratories Ltd.,) with Lotrel® capsules Novartis Pharmaceuticals Corporation in healthy human subjects under fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules
Vimta Labs Ltd.
Hyderabad, A.P, India
Bioequivalence is based on Cmax and AUC parameters
Time frame: 3 months
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