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Shaun Sabico

Assistant Professor

Assistant Professor and Deputy Director

كلية العلوم
Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, KSU
المنشورات
مقال فى مجلة
2008

Bioequivalence of Jusline following subcutaneous administration in healthy subjects

OBJECTIVE:

The aim of the current work is to evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin preparation (jusline) following subcutaneous administration in healthy subjects, and to compare this profile with Humulin insulin.

METHODS:

20 healthy male subjects received a single dose of 0.2 U/kg of test (Jusline) or reference insulin (Humulin) during an euglycemic clamp keeping blood sugar constant (90 +/- 5 mg/dl) by changing the glucose infusion rate. Pharmacokinetic and pharmacodynamic measurements were taken from blood measurements of glucose, insulin, and C-peptide levels for tested insulin formulations.

RESULTS:

The mean values of the individual AUC ratios were well within the 90% confidence interval (100.5% for Regular, 101.9% for NPH, and 100.0% for Premixed Regular/NPH (30/70)). Similarly, Cmax and tmax were within the bioequivalence limit (80 - 125%). The maximum GIR were 10.20 mg/kg/min and 9.72 mg/kg/min for Jusline Regular and Humulin Regular, respectively. The maximum GIR were 7.09 mg/kg/min and 7.91 mg/kg/min for Jusline NPH and Humulin NPH, respectively. The maximum GIR and tGIRmax were 6.39 mg/kg/min and 6.63 mg/kg/ min for Jusline Premixed Regular/NPH (30/70) and Humulin Premixed Regular/NPH (30/70), respectively. Both insulin products produced similar suppression of endogenous C-peptide level (-29.76% to -50.22%).

CONCLUSION:

The present study demonstrated that after subcutaneous administration, there are no significant differences between Jusline and Humulin to promote peripheral glucose uptake.

نوع عمل المنشور
Phase 1 Clinical Trial
رقم المجلد
46
رقم الانشاء
7
مجلة/صحيفة
International Journal of Pharmacology and Therapeutics 2008
الصفحات
32-38
مزيد من المنشورات
publications

Hyperglycemia associated with prediabetes (PD) alters NLRP3 inflammasome activity and related interleukins, yet no study has evaluated the expression of the NLRP3 inflammasome complex and related…

بواسطة Alfadul H, Sabico S, Alnaami AM, Amer OE, Hussain SD, Wani K, Clerici M, Al-Daghri NM
2023
تم النشر فى:
MDPI
publications

Objectives

بواسطة Aljuraiban GS, Algabsani S, Sabico S, Alshammari S, Aljazairy E, Al-Musharaf S
2023
تم النشر فى:
Elsevier
publications

The Metabolically Healthy Obese (MHO) is a unique phenotype of obesity in which individuals match the operational definition of obesity but do not display metabolic complications. Given this…

بواسطة Kaiser Wani , Balvir Kumar , Iram Saba , Shaun Sabico
2023
تم النشر فى:
Biolife Sas