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Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition

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

Summary

Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition.

Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting condition.

Study Design

N/A

Conditions

Type 2 Diabetes

Intervention

Metformin

Location

Torrent Research Centre
Bhat
Gujarat
India
382 428

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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