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Bioequivalency Study of Amlodipine Tablets Under Fed Conditions

2014-08-27 03:33:28 | BioPortfolio

Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hypertension

Intervention

Amlodipine

Location

Gateway Medical Research, Inc.
St. Charles
Missouri
United States
63301

Status

Completed

Source

Roxane Laboratories

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:28-0400

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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.

A condition in pregnant women with elevated systolic (>140 mm Hg) and diastolic (>90 mm Hg) blood pressure on at least two occasions 6 h apart. HYPERTENSION complicates 8-10% of all pregnancies, generally after 20 weeks of gestation. Gestational hypertension can be divided into several broad categories according to the complexity and associated symptoms, such as EDEMA; PROTEINURIA; SEIZURES; abnormalities in BLOOD COAGULATION and liver functions.

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