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Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.

2014-08-27 03:15:09 | BioPortfolio

Summary

Objective:

To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fed Conditions.

Study Design:

An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study

Study Design

N/A

Conditions

Type 2 Diabetes

Intervention

Metformin

Status

Completed

Source

Torrent Pharmaceuticals Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:09-0400

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.

A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

An analog of GLUCAGON-LIKE PEPTIDE 1 and agonist of the GLUCAGON-LIKE PEPTIDE 1 RECEPTOR that is used as a HYPOGLYCEMIC AGENT and supplemental therapy in the treatment of DIABETES MELLITUS by patients who do not respond to METFORMIN.

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