Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fasting Conditions
Summary
The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fasting conditions.
Description
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy volunteers with a washout period of 14 days.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Healthy
Intervention
Amlodipine
Location
AAI Clinic
Chapel Hill
North Carolina
United States
27514
Status
Completed
Source
Dr. Reddy's Laboratories Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01131923
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Amlodipine
A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
Clinical Trials
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone
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The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensiv...
PubMed Articles
Most patients with hypertension will require treatment with at least two antihypertensive agents to achieve blood pressure (BP) control. This double-blind study evaluated the efficacy and safety of al...
The steady-state pharmacokinetic (PK) interaction potential between amlodipine (10 mg), valsartan (320 mg), and hydrochlorothiazide (HCTZ; 25 mg) was evaluated in patients with hypertension in a multi...
Objective: To enhance the oral absorption of photosensitive amlodipine free base, which exhibits a slow dissolution rate and low permeability characteristics, an amorphous solid dispersion system was...
Abstract Aim. To compare two strengths of a fixed drug combination (FDC) containing metoprolol XL and amlodipine (metoprolol/amlodipine 50/5; and metoprolol/amlodipine 25/2.5) with its components in...
Effective antihypertensive therapy is crucial for preventing cardiovascular events; however, blood pressure (BP) control rates remain poor. The objective of this analysis was to determine the efficacy...
