CHEMOTHERAPY SEPT. 1991

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CHEMOTHERAPY SEPT. 1991

VOL. 39 S-3 Table 1. Background of characteristics and allocation of 9 healthy male volunteers in a single-dose study on betamipron

Table 2. Background of characteristics and allocation of 22 healthy male volunteers in a single-dose study on panipenem/betamipron

VOL 39 S-3 Fig. 1. Schedule of single-dose study on betamipron (Study no. I) Fig. 2. Schedule of single-dose study on panipenem/betamipron (Study no. II)

CHEMOTHERAPY SEPT.1991 Fig. 3. Schedule of single-dose study on panipenem/betamipron (Study no. III) Table 3. Clinical laboratory tests Items 1) Signs and symptoms 2) Physical examination: blood pressure, pulse rate, body temperature, respiratory rate, ECG 3) Laboratory tests a) Hematology: RBC, hemoglobin, hematocrit, WBC and differential counts, platelets, reticulocytes, MCV, MCI-I, MCHC, PT, APTT, fibrinogen ) Blood chemistry: GOT, GPT, AL-P, LDH, LAP, y-gtp, b CK, amylase, T-protein BUN, creatinine, UA, Na, K, CI, Ca, P, Mg, glucose, T-chol, albumin, A/G,, triglyceride, T-bil, D-bil, CRP, Coombs' test c) Urinalysis: protein, glucose, urohilinogen, blood, ketones, specific gravity, sediment d) Others: NAG,ƒÀ2-microglohulin, creatinine clearance, skin test

VOL. 39 S-3 Table 4. Plasma concentration of betamipron after an intravenous injection of betamipron in healthy volunteers (Study no. I) * Time after administration Fig. 4. Plasma concentration after an intravenous injection of 250mg(- -), 500mg (- -) and 1000mg (- -) betamipron in healthy volunteers. Fig. 5. Plasma concentration of panipenem during and after administration of panipenem/betamipron in healthy volunteers (Mean }S.D.) (Meant S.D. of 3 subjects)

Table 5. Pharmacokinetic parameters of betamipron after an intravenous injection of betamipron in healthy volunteers (Study no.i) Table 6. Urinary concentration and cumulative urinary excretion of betamipron after an intravenous injection of betamipron in healthy volunteers (Study no. 1) * Time after administration

Table 7. Plasma concentration of panipenem after an intravenous drip infusion of panipenem/betamipron in healthy volunteers (Study no. II and III) * Time after administration

CHEMOTHERAPY SEPT. 1991

VOL.39 S-3 Table 9. Urinary concentration and cumulative urinary excretion of panipenem after an intravenous drip infusion of panipenem/betamipron in healthy volunteers (Study no. II and III) *Time after administration

CHEMOTHERAPY SEPT.1991 Table 10. Plasma concentration of R976-2 during and after an intravenous drip infusion of panipenem/betamipron in healthy volunteer (Study no. II) * Time after administration Fig. 6. Plasma concentration of betamipron during and after administration of panipenem/betamipron in healthy volunteers (Meant S.D.)

VOL. 39 S-3 Table 11. Urinary concentration and cumulative urinary excretion of R976-2 after an intravenous drip infusion of panipenem/betamipron in healthy volunteers (Study no. II and III) * Time after administration

CHEMOTHERAPY SEPT. 1991 Table 12. Plasma concentration of betamipron after an intravenous drip infusion of panipenem/betamipron in healthy volunteers (Study no.ii and III) * Time after administration

VOL.39 S-3

CHEMOTHERAPY SEPT. 1991 Table 14. Urinary concentration and cumulative urinary excretion of betamipron after an intravenous drip infusion of panipenem/betamipron in healthy volunteers (Study no. II and III) * Time after administration

VOL.39 S-3 Fig. 7. Dose-AUC (A) and dose-urinary recovery (B) relationships of panipenem after administration of panipenem/betamipron (Mean }S. D.)

CHEMOTHERAPY SEPT.1991

VOL.39 S-3

CHEMOTHERAPY

VOL 39 S-3 Table 16-2. Clinical laboratory findings in single-dose study on panipenem/betamipron (Study no. II) Bef: before administration Aft: 22 hours after administration

CHEMOTHERAPY SEPT.1991 Table 16-3 Clinical laboratory findings in single-dose study on panipenem/betamipron (Study no. II) Bef: before administration Aft: 22 hours after administration

VOL.39 S-3 Table 17. Clinical laboratory findings in single-dose study on panipenem/betamipron (Study no. III) Bef: before administration

CHEMOTHERAPY 1) Sugawara S, Miyadera T, Sugimura Y, Goto S, and Kuwahara S: RS-533, a new carbapenem compound. in vitro and in vivo antibacterial activity. Proceedings of 22nd ICAAC (Miami Beach): 4-6, 1982 5) Birnbaum J, Kahan M F, Kropp H, and Macdonald J S: Carbapenem, A new class of Ĉlactam antibiotics. American J Med 78 (6A): 3-21, 1985 PHASE I STUDY OF PANIPENEM/BETAMIPRON I Mitsuyoshi Nakashima1), Toshihiko Uematsu1), Mitsutaka Kanamaru2), Masazo Tajima3), Hideo Naganuma4) Masafumi Hisaoka4), Yukinori Kawahara5), and Hideki Takahagi5) Department of Pharmacology, Hamamatsu University, 1) School of Medicine 3600 Handa-cho, Hamamatsu 431-31, Japan 2)Shinpukai Maruyama Hospital New Drug Development 3) Department, Sankyo Co., Ltd. Product development Laboratories, Sankyo Co., Ltd. 4) 5)Analytical and Metabolic Research Laboratories, Sankyo Co., Ltd. The tolerability and pharmacokinetics of panipenem/betamipron (PAPM/BP), a new injectable carbapenem derivative, were examined in 31 healthy male volunteers in single-dose study. In the single-dose study of betamipron(bp), 9 subjects were given a dose of 250, 500 or 1000mg of BP and 22 subjects were given a dose of 125/125, 250/250, 500/500, 750/750 or 1000mg/1000mg of PAPM/ BP in a fastings state. Both BP and PAPM/BP were well tolerated by all subjects. Adverse effect was not observed. The maximun plasma levels of panipenem (PAPM) were observed at the end of the injection and their levels showed dose-dependence. The half-life was about 70 min. Urinary recovery of PAPM was approximately 30%. On the other hand, BP was 100%.

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