Safety and efficacy of AJG522 as a bowel cleansing agent for colonoscopy in healthy Japanese subjects

MOVIPREP^®, originally developed by Norgine, has been marketed in Europe and North America and is the world's most frequently administered bowel preparation prior to colonoscopy. However, MOVIPREP8 is not yet marketed in Japan. AJG522 is essentially similar to MOVIPREP8 but Macrogol (PEG) 3350, one of the main active ingredients of MOVIPREP8, is replaced by Macrogol 4000 in accordance with Japanese Pharmacopoeia. The objective of the present study was to evaluate the safety and efficacy of AJG522 in healthy Japanese subjects. This study consisted of two steps. In step 1, 12 subjects were administered 1 liter of AJG522 and 0.5 liter of water and repeated twice. They were evaluated for safety and pharmacokinetics of ascorbic acid. In step 2, 50 subjects were administered 1 liter of AJG522 and 0.5 liter of water, and then administered AJG522 until their stool became clear, or 1 liter of AJG522. In both cases the subjects were administered water at half the volume of AJG522. They were also evaluated for safety, pharmacokinetics of ascorbic acid, and cleanliness of the entire colon by colonoscopy. These preparations were well tolerated. One participant dropped out in step 2 before colonoscopy because of eruption, which was mild and resolved without treatment. Successful intestinal cleansing was achieved in 49/49 (100%). This study suggests that AJG522 is safe and useful as a preparation for total colonoscopy.