International Bio Service Co., Ltd., 888 Golden Jubilee Medical Center, Mahidol University, Nakhon Pathom 73170, Thailand
Research Article
Bioequivalence Study of Molnupiravir 200 mg Capsules in Healthy Thai Volunteers
Author(s): Vipada Khaowroongrueng*, Jaturavit Vattanarongkup, Sumete Kunsa-ngiem, Wiwat Supasena, Lalinthip Saeaue, Busarat Karachot, Piengthong Narakorn, Isariya Techatanawat and Porranee Puranajoti
The antivirals inhibiting RNA-Dependent RNA Polymerase (RdRp) enzyme seem to be the most effective therapeutic solution for a Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Molnupiravir is a prodrug of N-Hydroxycytidine (NHC) which is subsequently phosphorylated to NHC triphosphate, thereby targeting RdRp and inducing error catastrophe. In response to the treatment demands within the national public health system during the COVID-19 pandemic, the Government Pharmaceutical Organization (GPO), Thailand had developed a generic product of molnupiravir 200 mg capsules. An open label, randomized, two-treatment, two-period, two-sequence, single oral-dose, crossover study was designed to determine the bioequivalence of two molnupiravir 200 mg capsule formulations, MONOVIR® and LAGEVRIO® under fasting conditions. The plasma-concentration time profiles of NHC were used to.. View more»