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Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal

2015-12-21 06:04:45 | BioPortfolio

Published on BioPortfolio: 2015-12-21T06:04:45-0500

Clinical Trials [3299 Associated Clinical Trials listed on BioPortfolio]

Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal

This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin, Huminsul...

Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III

This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Humins...

A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM

This is a single centre, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus. Each subject will be administered individualis...

A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Ty

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorpti...

Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes

This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid...

PubMed Articles [16879 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.

For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015...

Efficacy and Safety of MYL-1501D Versus Insulin Glargine in Patients With Type 1 Diabetes After 52 Weeks: Results of the Phase 3 INSTRIDE 1 Study.

Insulin glargine, a long-acting human insulin analogue, allows for once-daily basal use in patients with type 1 diabetes mellitus (T1DM). MYL-1501D is a proposed insulin glargine biosimilar.

Direct comparison of LC-MS/MS and RIA methods for the pharmacokinetics assessment of human insulin in preclinical development.

Insulin is an effective therapeutic for diabetes, and the level of insulin in vivo is directly related to the health of diabetic patients. Traditionally, the concentrations of insulin in vivo were det...

Liver-specific ablation of insulin-degrading enzyme causes hepatic insulin resistance and glucose intolerance, without affecting insulin clearance in mice.

The role of insulin-degrading enzyme (IDE), a metalloprotease with high affinity for insulin, in insulin clearance remains poorly understood.

Postoperative insulin secretion is decreased in patients with preoperative insulin resistance.

Postoperative hyperglycemia is associated with increased rate of surgical site infection, renal failure, and cardiovascular events. The study of insulin sensitivity state before surgery could help in ...

Medical and Biotech [MESH] Definitions

A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.

Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS. It can be caused by the presence of INSULIN ANTIBODIES or the abnormalities in insulin receptors (RECEPTOR, INSULIN) on target cell surfaces. It is often associated with OBESITY; DIABETIC KETOACIDOSIS; INFECTION; and certain rare conditions. (from Stedman, 25th ed)

Regular insulin preparations that contain the HUMAN insulin peptide sequence.

A blood protein (NSILA) which mimics the biological activity of insulin in serum, but is not suppressed by insulin antibodies. During acid-ethanol extraction of Cohn fraction III, 10% of the activity is found in the supernatant (NSILA-S) and the remaining activity in the precipitate (NSILA-P). The latter is a large molecular compound, much less stable than the soluble fraction. NSILA-S is a more potent growth factor than insulin and exhibits sulfation activity.

An insulin preparation that is designed to provide immediate and long term glycemic control in a single dosage. Biphasic insulin typically contains a mixture of REGULAR INSULIN or SHORT-ACTING INSULIN combined with a LONG-ACTING INSULIN.

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