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Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Rosuvastatin Calcium Tablets Under Fed Conditions

2016-11-15 11:38:21 | BioPortfolio

Summary

Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of studies were separated by a washout period of 7 days.

Description

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Rosuvastatin Calcium Tablets containing Rosuvastatin Calcium 40 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Crestor® 40 mg Tablets containing Rosuvastatin Calcium 40 mg (Reference , AstraZeneca Pharmaceuticals LP, USA) in Healthy Human Volunteers Under Fed Condition.

Study Design

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

Conditions

Healthy Subjects

Intervention

Torrent's Rosuvastatin Calcium Tablets 40 mg, Crestor 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA

Status

Completed

Source

Torrent Pharmaceuticals Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-15T11:38:21-0500

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Bio Equivalence Study of Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets Under Fasting Condition.

Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of st...

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Medical and Biotech [MESH] Definitions

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.

A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.

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Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.

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