VOMITING IS A POTENTIAL ADVERSE DRUG REACTION FOR LEVOMILNACIPRAN
Journal Title: International Journal of Pharmaceutical Sciences and Drug Research - Year 2017, Vol 9, Issue 5
Abstract
Levomilnacipran is a drug used to treat depression. Micro Labs is a generic drug company which had developed an extended release formulation of Levomilnacipran 120 mg capsule. Two studies were conducted to assess the safety, tolerability and bioequivalence of the extended release formulation of 120 mg Levomilnacipran capsules. A total of 42 subjects had been included for each of the fasting and fed studies. Out of them, 30 subjects completed the fasting study and 28 subjects completed the fed study. Pharmacokinetic parameters like Cmax, AUC0-t, AUC0-inf, Tmax, Kel, t1/2 and %AUCextra were calculated for Levomilnacipran in order to compare the bioavailability of the test and reference formulations. The studies were conducted in healthy human volunteers in both fasting and fed conditions as per the US regulatory requirements for conduct of bioequivalence studies. The formulations were found to be bioequivalent to each other. Vomiting was observed as a major adverse reaction.
Authors and Affiliations
Atreyee Sarkar, Shivanand Dhanure
MEDICATION KNOWLEDGE LEVEL OF HYPERTENSIVE PATIENTS FROM SOUTH INDIAN HOSPITALS
To estimate the patient’s antihypertensive medication knowledge from south Indian population. Five hundred (500) patients were participated in this study. Out of 500, 46 patients were pre hypertensive so 456 patients wer...
ESTIMATION OF ELETRIPTAN HYDROBROMIDE IN ORAL FILM DOSAGE FORM BY RP-HPLC
A simple, precise, rapid and accurate RP-HPLC method was developed for the percentage drug release estimation of Eletriptan Hydrobromide in oral film dosage form. Eletriptan Hydrobromide is used to treat severe migraine...
ANTIULCER ACTIVITY OF METHANOLIC EXTRACT OF ROOTS OF BETA VULGARIS, CHENOPODIACEAE
Beta vulgaris (chenopodiacea) is a medicinal plant reported for its variety of ethnic medicinal uses. Beta vulgaris showed antioxidant, anticancer, hepatoprotective, nephroprotective, wound healing, and an...
EFFECT OF PHOSPHATASES ACTIVITY IN THE HEPATOPANCREAS AND MUSCLE OF THE FRESH WATER FEMALE FIELD CRAB, SPIRALOTHELPHUSA HYDRODROMA (HERBST) TREATED WITH CYPERMETHRIN
The fresh water field crab, Spiralothelphusa hydrodroma is an important human food source in parts of South India and the crab is constantly exposed to pesticides, which are used extensively to control agricultural pests...
DEVELOPMENT AND VALIDATION OF RP-HPLC ASSAY METHOD FOR VILDAGLIPTIN USING QBD APPROACH AND ITS APPLICATION TO FORCED DEGRADATION STUDIES
The concept of Quality by design (QbD) has recently gained importance in the area of analytical method development and involves understanding of the critical factors and their interaction effects by a desired set of expe...