Phase I Clinical Studies of 7432‐S: Effect of 7432‐S on Platelet Aggregation and Blood Coagulation

Nakashima, Mitsuyoshi; Takiguchi, Yoshiharu; Mizuno, Atsuhiro; Uchida, Keiji; Matsubara, Takashi

doi:10.1002/j.1552-4604.1988.tb03141.x

Cited by 8 publications

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Phase I Clinical Studies of 7432‐S, a New Oral Cephalosporin: Safety and Pharmacokinetics

Nakashima

Takiguchi

Mizuno

et al. 1988

The Journal of Clinical Pharma

View full text Add to dashboard Cite

Phase I clinical studies of 7432-S, a new oral cephalosporin, including a randomized placebo-controlled trial were conducted with 40 healthy volunteers. In single-dose studies, 7432-S was orally administered at doses of 25, 50, 100, and 200 mg. The mean plasma levels peaked at 2.1 to 3.0 hours and reached 1.9, 3.6, 5.6, and 11.6 micrograms/ml, respectively. Linear correlation was observed between plasma AUC values and doses given. The half-lives of the plasma levels were 0.88 to 2.26 hours with a mean of 1.53 +/- 0.33 hours. The mean urinary recoveries were 67.5 to 75.2% of the dose within 24 hours. 7432-S was partially metabolized to 7432-S-trans which was excreted in urine at 7.2 to 9.2% of the doses. Study of the meal effect showed that AUC values and peak levels were not altered although the time to the peak levels was slightly prolonged. In multiple-dose studies, 100 mg of 7432-S twice daily for 2 weeks and 200 mg twice daily for 1 week were administered and there was no abnormal accumulation of 7432-S in plasma throughout the study. No significant differences were observed in plasma levels and urinary recoveries between single- and multiple-dose regimens. Clinical symptoms, physical tests, laboratory parameters, and fecal levels of vitamins K1 and K2 were in normal ranges. 7432-S was concluded to be safe and well tolerated.

show abstract

Phase I Clinical Studies of 7432‐S, a New Oral Cephalosporin: Safety and Pharmacokinetics

Nakashima

Takiguchi

Mizuno

et al. 1988

The Journal of Clinical Pharma

View full text Add to dashboard Cite

show abstract

Ceftibuten: An Overview

Owens,

Nightingale,

Nicolau

1997

Pharmacotherapy

View full text Add to dashboard Cite

Ceftibuten is an orally active third‐generation cephalosporin that exhibits good microbiologic activity against many gram‐negative and select gram‐positive organisms. It is stable against plasmid‐mediated β‐lactamases, including extended‐spectrum β‐lactamases. Ceftibuten has been shown to be effective in the treatment of upper and lower respiratory tract infections and, although not approved indications, complicated and uncomplicated urinary tract infections in both adults and children. It is readily absorbed (75–90%) after oral administration, with peak serum levels of 17 μg/ml in healthy volunteers. Its half‐life is 2.5 hours in healthy volunteers and is increased in elderly patients to approximately 3.2 hours. Elimination occurs primarily through the kidneys, requiring dosage adjustments to be made when creatinine clearance falls below 50 ml/minute. The drug's safety profile is favorable and similar to that of most other cephalosporins. Based on pharmacokinetic information and clinical trial data, ceftibuten can be dosed once/day for most infections. It is an alternative to other currently available antimicrobial agents in the treatment of indicated upper and lower respiratory tract infections.

show abstract

Antimicrobial activity and spectrum of ceftibuten (7432-S, SCH 39720) a review of United States and canadian results

Jones

1991

Diagnostic Microbiology and Infectious Disease

View full text Add to dashboard Cite

Phase I Clinical Studies of 7432‐S: Effect of 7432‐S on Platelet Aggregation and Blood Coagulation

Cited by 8 publications

References 18 publications

Phase I Clinical Studies of 7432‐S, a New Oral Cephalosporin: Safety and Pharmacokinetics

Phase I Clinical Studies of 7432‐S, a New Oral Cephalosporin: Safety and Pharmacokinetics

Ceftibuten: An Overview

Antimicrobial activity and spectrum of ceftibuten (7432-S, SCH 39720) a review of United States and canadian results

Contact Info

Product

Resources

About