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A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets

2014-08-27 03:19:56 | BioPortfolio

Summary

A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).

Study Design

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

Conditions

Type 2 Diabetes

Intervention

sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500 mg, Comparator: sitagliptin, Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet, Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet, Comparator: metformin

Status

Completed

Source

Merck

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:56-0400

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PubMed Articles [1973 Associated PubMed Articles listed on BioPortfolio]

Effect of Food on the Pharmacokinetics of Ertugliflozin and Its Fixed-Dose Combinations Ertugliflozin/Sitagliptin and Ertugliflozin/Metformin.

Ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, is approved in the United States and European Union for the treatment of type 2 diabetes in adults, both as monotherapy and as part of fi...

Efficacy and safety of replacing sitagliptin with canagliflozin in real-world patients with type 2 diabetes uncontrolled with sitagliptin combined with metformin and/or gliclazide: The SITA-CANA Switch Study.

To analyze the efficacy and safety of replacing sitagliptin with canagliflozin in patients with type 2 diabetes (T2D) and poor metabolic control despite treatment with sitagliptin in combination with ...

SHORT-TERM SITAGLIPTIN-METFORMIN THERAPY IS MORE EFFECTIVE THAN METFORMIN OR PLACEBO IN PRIOR GESTATIONAL DIABETIC WOMEN WITH IMPAIRED GLUCOSE REGULATION.

Liraglutide, sitagliptin and insulin glargine added to metformin: the effect on body weight and intrahepatic lipid in patients with type 2 diabetes mellitus and NAFLD.

To investigate the effect of anti-diabetic agents on nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes (T2DM), 75 patients with T2DM and NAFLD under inadequate glycemic control...

Metformin, Sitagliptin, and Liraglutide modulate serum retinol binding protein -4 level and adipocytokines production in type 2 diabetes mellitus rat model.

Many adipocytokines correlate with obesity and insulin resistance(IR). we examined the effects of metformin, sitagliptin, and liraglutide in diabetic rats. Group 1: control normal (CN) received oral s...

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)

A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.

A biguanide hypoglycemic agent with actions and uses similar to those of METFORMIN. Although it is generally considered to be associated with an unacceptably high incidence of lactic acidosis, often fatal, it is still available in some countries. (From Martindale, The Extra Pharmacopoeia, 30th ed, p290)

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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