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Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

2014-08-27 03:13:08 | BioPortfolio

Summary

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 bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Healthy Volunteers

Intervention

Amlodipine - reference, Amlodipine ODT - test, Amlodipine ODT - test

Status

Not yet recruiting

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:08-0400

Clinical Trials [5548 Associated Clinical Trials listed on BioPortfolio]

Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

The purpose of the study is to compare the bioavailability of a generic product of amlodipine with that of a reference product when administered to healthy volunteers under fasting conditi...

Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

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

To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately control...

Amlodipine 10 mg Tablets Under Fed Conditions

The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg...

Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating tablet and 5 mg amlodipine 2nd Orally-Disintegrating tablet are bioequivalent

PubMed Articles [14522 Associated PubMed Articles listed on BioPortfolio]

Validated LC-MS/MS method for the determination of amlodipine enantiomers in rat plasma and its application to a stereoselective pharmacokinetic study.

A rapid and sensitive method was established to determine amlodipine enantiomers using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Stereoselective separation was performed on CHIRALCEL ...

Low Levels of Amlodipine in Breast Milk and Plasma.

Few clinical reports have addressed the use of the antihypertensive drug amlodipine during breastfeeding. The objective of this study is to characterize concentration-time profiles of amlodipine in ma...

A retrospective study evaluating the tolerability and effectiveness of adjunctive antihypertensive drugs in patients with inadequate response to initial treatment.

Real-world tolerability and effectiveness of nebivolol as first add-on therapy were compared with hydrochlorothiazide, metoprolol, and amlodipine. Medical records of hypertensive adults initiating neb...

Drug-in-mucoadhesive type film for ocular anti-inflammatory potential of amlodipine: Effect of sulphobutyl-ether-beta-cyclodextrin on permeation and molecular docking characterization.

Mucoadhesive type ocular film has been prepared for studying the anti-inflammatory potential of amlodipine (AML) on carrageenan-induced rabbit model and the effect of sulphobutyl-ether-beta-cyclodextr...

Effects of amlodipine and valsartan on glibenclamide-treated streptozotocin-induced diabetic rats.

Diabetes mellitus (DM) is a spectrum of metabolic disorders, arising from pathologic mechanisms, resulting in hyperglycaemia. Diabetes and hypertension frequently occur together and are leading risk f...

Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of amlodipine and valsartan that is used for the treatment of HYPERTENSION.

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.

A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.

Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)

Negative test results in subjects who possess the attribute for which the test is conducted. The labeling of diseased persons as healthy when screening in the detection of disease. (Last, A Dictionary of Epidemiology, 2d ed)

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