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.
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.
Liu
Ping
P
Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China.
Liang
Sun
S
Wang
Ben-Jie
BJ
Guo
Rui-Chen
RC
D000328:Adult; D002681:China; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004562:Electrocardiography; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D013058:Mass Spectrometry / Q000379:methods*; D011398:Promethazine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D011446:Prospective Studies; D014147:Tramadol / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D055815:Young Adult
D004338:Drug Combinations; D014147:Tramadol; D011398:Promethazine