Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
Summary
The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fed 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
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/NCT01131936
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:22-0400
Clinical Trials
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This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone
Filtered Trial for Amlodipine Non-responder
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This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the ...
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
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PubMed Articles
Amlodipine, a commonly prescribed anti-hypertensive drug, shows increased systemic exposure with cytochrome P450 (CYP) 3A inhibitors. Ritonavir (RTV) is a potent mechanism-based and reversible CYP3A i...
A sensitive and specific method, utilising high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) was developed for the quantitative determination of amlodipine in dried blood sp...
Two Fatal Cases Involving Cardiovascular Drugs Diltiazem and Amlodipine.
A liquid chromatographic tandem mass spectrometric method for the identification and quantification of 18 cardiovascular drugs was developed in order to evaluate two cases of fatal intoxication involv...
Fixed dose combination (FDC) of valsartan (VAL) and hydrochlorothiazide (HCT) or VAL and amlodipine (AML) has been available in many countries for the treatment of hypertension. Due to drug-drug inter...
The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia.
Medical and Biotech [MESH] Definitions
Amlodipine, Valsartan Drug Combination
A pharmaceutical preparation of amlodipine and valsartan that is used for the treatment of HYPERTENSION.
Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
A pharmaceutical preparation of amlodipine besylate and olmesartan medoxomil that combines ANGIOTENSIN II TYPE I RECEPTOR ANTAGONIST and CALCIUM CHANNEL BLOCKER activities. It is used in the management of HYPERTENSION.
Healthy People Programs
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Amlodipine
A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
Nutrition Policy
Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
