Article Per Year (5 Year)
p-Index From 2021 - 2026
0
P-Index
This Author published in this journals
All Journal Journal of Global Pharma Technology
Geliya Gildeeva
Unknown Affiliation
Medicine & Pharmacology

Published : 1 Documents Claim Missing Document
Claim Missing Document
Check
Articles

Found 1 Documents
Search

 1 
Bioequivalence Study of Morphine Hydrochloride Oral Solution versus Immediate Release Tablets Geliya Gildeeva; Andrey Belostotsky; Ekaterina Ezhova; Vladimir Yurkov
Journal of Global Pharma Technology Volume 11 Issue 6.
Publisher : Journal of Global Pharma Technology

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (476.386 KB)

Abstract

Objective: Comparative study of bioequivalence and safety of Morphine Hydrochloride 2 mg/ml oral solution (T) and Morphine Hydrochloride 10 mg immediate release film-coated tablets (R) after single dose administration (1 ampoule 5 ml, 2 mg/ml / 1 tablet 10 mg) by healthy subjects under fasting conditions. Methods: Open-label, single dose, 2-period crossover, randomized design study in 42 healthy subjects under fasting conditions. Test product: Morphine Hydrochloride 2 mg/ml oral solution (FSUE «Moscow Endocrine Plant», Russia) was compared with the reference product Morphine Hydrochloride 10 mg Immediate Release Tablets (FSUE «Moscow Endocrine Plant», Russia) under fasting conditions. The statistical method is testing for Cmax, AUC0-t and AUC0-∞. Bioequivalence study was based upon the 90% confidence interval (90% CI) for the test and reference geometric mean ratio. Bioequivalence was to be assumed if 90% CI fell within the recommended acceptance interval 80%; 125%.Results:Forty-two subjects completed the study. Both Morphine T and Morphine R exhibited peak plasma Morphine concentrations of ~13 ng/ml. 90% CIs of the ln-transformed values of Morphine AUC0-t and Cmax were within 80% to 125% range for bioequivalence. The most common adverse events were anemia and headache. These data show that, in these subjects, Morphine T was bioequivalent to Morphine R, a treatment for pain with well-established efficacy and safety profiles.
Co-Authors Andrey Belostotsky Ekaterina Ezhova Vladimir Yurkov