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

Hidetoshi Furuie, Hiroshi Hirato, Michio Yagi, Tsutomu Sakurai, Saiko Yamada, Mitsunori Seki, Yutaka Endo, Masahiro Igarashi, Nagamu Inoue, Fumiaki Ueno

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)53-60
Number of pages8
JournalJapanese Journal of Clinical Pharmacology and Therapeutics
Volume44
Issue number2
DOIs
Publication statusPublished - 2013 Mar

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Colonoscopy
Detergents
Healthy Volunteers
Safety
Ascorbic Acid
Water
Pharmacokinetics
Pharmacopoeias
North America
Japan
Colon
Therapeutics

Keywords

  • AJG522
  • Colonoscopy
  • MOVIPREP

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology

Cite this

Safety and efficacy of AJG522 as a bowel cleansing agent for colonoscopy in healthy Japanese subjects. / Furuie, Hidetoshi; Hirato, Hiroshi; Yagi, Michio; Sakurai, Tsutomu; Yamada, Saiko; Seki, Mitsunori; Endo, Yutaka; Igarashi, Masahiro; Inoue, Nagamu; Ueno, Fumiaki.

In: Japanese Journal of Clinical Pharmacology and Therapeutics, Vol. 44, No. 2, 03.2013, p. 53-60.

Research output: Contribution to journalArticle

Furuie, Hidetoshi ; Hirato, Hiroshi ; Yagi, Michio ; Sakurai, Tsutomu ; Yamada, Saiko ; Seki, Mitsunori ; Endo, Yutaka ; Igarashi, Masahiro ; Inoue, Nagamu ; Ueno, Fumiaki. / Safety and efficacy of AJG522 as a bowel cleansing agent for colonoscopy in healthy Japanese subjects. In: Japanese Journal of Clinical Pharmacology and Therapeutics. 2013 ; Vol. 44, No. 2. pp. 53-60.
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