[Non-steroidal anti-inflammatory agent, phase I clinical trial with CN-100--single and repeated oral administration study].
In vivo pharmacokinetics and safety of CN-100, a propionic acid derivative non-steroidal anti-inflammatory drug (NSAID), were investigated in 12 healthy male volunteers with single oral administration at a dose of 150 or 300 mg, or repetitive oral administrations at a daily dose of 300 mg. The plasma concentration of CN-100 reached maximum approximately 1.5 hrs. after the administration and disappeared from the body with a half-life of about seven hrs. No cumulative effect was confirmed by the repetitive administration. The in vivo pharmacokinetics of CN-100 were not affected by a meal one hr. prior to the administration. In clinical examinations, slight elevations of GOT and GPT were observed in one case, and slight increase of number of leucocyte was observed in two cases but no other notable subjective symptoms or objective findings were found. Thus, the pharmacokinetic and safety studies of CN-100 concluded that the drug is evaluable in phase II test under thorough examination and control.
Ishizaki
T
T
Division of Clinical Research Institute, National Medical Center, Tokyo.
Kubota
K
K
Echizen
H
H
Horai
Y
Y
Chiba
K
K
D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001582:Benzothiepins / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D006207:Half-Life; D006801:Humans; D008297:Male
D000894:Anti-Inflammatory Agents, Non-Steroidal; D001582:Benzothiepins; C051758:CN 100