CLINICAL PHASE I STUDY OF CEFTRIAXONE (Ro 13-9904)

DOI

Bibliographic Information

Other Title
  • Ceftriaxone (Ro 13-9904) の臨床第一相試験

Abstract

The clinical phase I study of ceftriaxone (CTRX, Ro 13-9904) was carried out in 20 healthy, male Japanese adults. Each subject received CTRX in the following order; 500 mg as a single i.v. injection, 1, 000 mg as a drip infusion for an hour, 1, 000 mg as a single i.v. injection and 1, 000 mg as series of 9 i.v. injections at intervals of 12 h. The safety and pharmacokinetic aspects of this drug were examined through the observation of the subjective and objective symptoms and the physical and clinical tests. Following results were obtained.<BR>1. The observation of the subjective and objective symptoms and the physical and clinical tests found no change due to this drug except for soft stool in some cases.<BR>2. The blood concentration when administered with 500 mg and 1, 000 mg as a single i.v. injection was almost in proportion to the dose, and the half-life time was 6.0 h and 6.6 h, respectively. In either dosage, around 50% was excreted into the urine within 48 h.<BR>3. The half-life time of the blood concentration when administered with 1, 000 mg as a single drip infusion was 7.1 h and 50% was excreted into the urine within 48 h, showing the same tendency as that of an i.v. injection at the equal dosage.<BR>4. The half-life time of the blood concentration when administered with 1, 000mg as series of 9 i.v. injections was 6.1 h at the first administration and 6.1 h at the last, suggesting no influence by the serial administration.<BR>5. The bile concentration 3 or 4 h after the final administration of 9 serial i.v. injections at intervals of 12 h was 170 to 4, 354 μg/ml in B bile and 92 to 518 μg/ml in C bile.

Journal

  • CHEMOTHERAPY

    CHEMOTHERAPY 32 (Supplement7), 178-196, 1984

    Japanese Society of Chemotherapy

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