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Pharmacokinetics, safety and tolerance of single- and multiple-dose of a novel compound tramadol hydrochloride injection (35 mg tramadol hydrochloride, 45 mgl promethazine hydrochloride) in Chinese healthy subjects

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Summary

The pharmacokinetics of Tramadol and Promethazine after a single dose of 40, 80 and 120 mg intramuscular injecting CTHI was evaluated in healthy volunteers. Physical exam, vital signs, clinical laboratory tests and electrocardiogram measurements were monitored to assess the safety and tolerance of the drug. The plasma levels of Tramadol and Promethazine in serial samples were measured by a validated HPLC-MS method. No subject showed any drug-related clinically significant changes on physical examination, vital signs or laboratory tests.

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Authors and Affiliations

  1. Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, 250012, Jinan, China

    Ping Liu, Ben-Jie Wang & Rui-Chen Guo

  2. Department of Cardiac Surgery, The Second Affiliated Hospital of Shandong Traditional Chinese Medicine University, 250001, Jinan, China

    Sun Liang

Authors
  1. Ping Liu
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  2. Sun Liang
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  3. Ben-Jie Wang
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  4. Rui-Chen Guo
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Corresponding author

Correspondence to Rui-Chen Guo.

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Liu, P., Liang, S., Wang, BJ. et al. Pharmacokinetics, safety and tolerance of single- and multiple-dose of a novel compound tramadol hydrochloride injection (35 mg tramadol hydrochloride, 45 mgl promethazine hydrochloride) in Chinese healthy subjects. Eur. J. Drug Metabol. Pharmacokinet. 34, 193–200 (2009). https://doi.org/10.1007/BF03191173

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  • DOI: https://doi.org/10.1007/BF03191173

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