Methylcobalamin injection 1500 mcg SC route versus IM route: A randomized parallel comparative bioavailability study

Abstract

Corona Remedies developed B-29 AQ PFS (Methylcobalamin Injection 1500 mcg) SC route for better patient compliance and ease of administration. The study outcome will explain pharmacokinetic behaviour of Methylcobalamin SC injection and non-inferiority over IM injection. The study was conducted to compare bioavailability, safety and tolerability of two different Methylcobalamin Injection formulation 1500 mcg with SC versus IM route. This was randomized, two treatment, parallel, comparative bioavailability study conducted on 24 normal, healthy, adult, human subjects. The dosage of the investigational product (IP) was given either as a 1500 mcg SC injection into the abdominal muscle or as an intramuscular injection into the gluteal muscle (buttock region) following an overnight fast of at least 10 hours. To assess the plasma concentrations of methylcobalamin, a number of blood samples were collected both before and after the injection. Maximum plasma concentration (C), time to maximum plasma concentration (T) and the area under the concentration-time curve (AUC) were compared. Pharmacokinetic (PK) parameters were statistically analysed using Statistical Analysis Software (SAS) Version 9.4 or above. The mean T for methylcobalamin absorption from SC administration and IM injection was 1.38 hours and 1.49 hours, respectively. In terms of bioavailability, the SC injection is comparable to the IM injection (the ratio of population geometric means for the SC and IM routes is 103.62 for AUC). In this study, a higher C for the SC route than the IM route was found (57.01 versus 45.82). Based on log transformed primary PK parameters (C and AUC), the geometric least squares mean ratio was observed >80.00%. According to safety evaluations, both therapies were safe and well-tolerated.Methylcobalamin is a safe and well-tolerated alternative to the current one that is non-inferior to IM route and faster in absorption after SC route.