Phase I Clinical Study of Biphasic Insulin Aspart 30 (BIAsp30)-The Safety, Pharmacokinetics and Pharmacodynamics of BIAsp30 compared to Biphasic Human Insulin-
|
Accession number;03A0530033
|
| Title;Phase I Clinical Study of Biphasic Insulin Aspart 30 (BIAsp30)-The Safety, Pharmacokinetics and Pharmacodynamics of BIAsp30 compared to Biphasic Human Insulin- |
| Author;
URAE AKINORI
(Aioikai)
IRIE SHIN
(Aioikai, Rinsho Yakuri Senta)
TANAKA TAKANORI
(Aioikai, Rinsho Yakuri Senta)
|
Journal Title;Journal of Clinical Therapeutics & Medicines
|
Journal Code:Y0906A
|
ISSN:0910-8211
|
|
VOL.19;NO.7;PAGE.733-742(2003)
|
| Figure&Table&Reference;FIG.3, TBL.7, REF.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To investigate the safety, pharmacokinetics and pharmacodynamics of Biphasic Insulin Aspart 30 (BIAsp30) compared to Biphasic Human Insulin 30 (30R) after single subcutaneous doses in fasting healthy male subject, a single-blind, single-centre, randomised, two-period crossover trial was conducted. Single subcutaneous doses of BIAsp30 and 30R were administered at a dose level of 0.15 U/kg, with a washout period of at least 7 days between dosing occasions. Sixteen subjects were randomised and enrolled in the trial in two groups of 8 subjects. All 16 subjects completed the trial as planned and were included in the analyses. Adverse events were not observed during the treatment period. Neither physiological examination nor laboratory test reveals any abnormalities that were attributable to the trial products or were of clinical relevance. No safety concerns were raised during this trial when used within the dose range of this study. When comparing the exogenous serum insulin (.DELTA.IRI) of BIAsp30 with 30R, the area under .DELTA.IRI-time curve from 0 to 360 min after dosing (AUC0-360min), from 0 to 600 min after dosing (AUC0-600min) and the maximum insulin concentration (Cmax) for BIAsp30 were significantly higher (p=0.0005, p=0.0070 and p<0.0001, respectively) than those for 30R. Tmax for BIAsp30 was significantly shorter (p=0.0003). When comparing the serum glucose from base line (.DELTA.BG) of BIAsp30 with 30R, Cmax and Tmax for BIAsp30 was significantly higher (p=0.0300) and shorter (p=0.0013) than those for 30R, respectively. There were no significant differences in tbe area over the .DELTA.BG-time curve from 0 to 360 min after dosing (AUC0-360min) and from 0 to 600 min after dosing (AUC0-600min) between BIAsp30 and 30R. In conclusion, adverse events were not observed during the treatment period, and no safety concerns were raised during this trial when used within the dose range of this study.... (author abst.) |
|
|
|
Related Articles;
|
|
