Elevated Serum Transaminase Values in Volunteers after Administration of Placebo in a Phase I Study.

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概要

• 論文の詳細を見る

• Serum transaminase (AST and ALT) values were monitored after administration of placebo to 104 healthy male volunteers for a phase I study. Both values remained within normal ranges in most of them. However, AST or ALT was above the normal range in 13 volunteers (12.5%). Their clinical features were ALT>AST, high serum γ-glutamyl trans peptidase, high serum triglyceride, high obesity index, or a combination of any of the four. We concluded that AST or ALT is likely elevated in volunteers showing these clinical signs; this should be noted in the evaluation of drug toxicity in future phase I studies.

著者

• Yamada Nobuo

  Department Of Dermatology Tokyo University Branch Hospital

• NISHIKAWA Takashi

  Clinical Pathology, Kitasato University School of Medicine

• KOBAYASHI Minae

  Division of Clinical Pharmacology, Kitasato University East Hospital

• SHIBATA Hisao

  Division of Clinical Pharmacology, Kitasato University East Hospital

• SHIBATA Hisao

  Division of Clincal Pharmacology, Kitasato University East Hospital

• KOBAYASHI Minae

  Division of Clincal Pharmacology, Kitasato University East Hospital

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• Elevation of Serum Transaminase Value after Administration of Non-toxic Drugs in Some Volunteers for Phase I Trials: A Study on the Selection of Volunteers.
• Elevated Serum Transaminase Values in Volunteers after Administration of Placebo in a Phase I Study.

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