Bioequivalence of Two Formulations of Biphasic Insulin Aspart 30 in Healthy Japanese Subjects
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Accession number;03A0624380
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| Title;Bioequivalence of Two Formulations of Biphasic Insulin Aspart 30 in Healthy Japanese Subjects |
| Author;
IRIE S
(Kyushu Chinical Pharmacology Res. Clinic)
FURUIE H
(Kyushu Chinical Pharmacology Res. Clinic)
MATSUGUMA K
(Kyushu Chinical Pharmacology Res. Clinic)
MURAKAMI M
(Kyushu Chinical Pharmacology Res. Clinic)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.8;PAGE.905-913(2003)
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| Figure&Table&Reference;FIG.2, TBL.3, REF.7 |
| Pub. Country;Japan |
| Language;English |
| Abstract;This trial was conducted to investigate whether a New-formulation of Biphasic Insulin Aspart 30 (BIAsp30) is bioequivalent to an Existing-formulation of BIAsp30 in healthy volunteers. Under fasting conditions, single subcutaneous (s.c) doses of each formulation of BIAsp30 were administered at a dose level of 0.15 U/kg, with a washout period of 6 to 21 days between the dosing occasions. The mean serum Insulin Aspart (IAsp) concentration profiles illustrate the rapid absorption of IAsp with both BIAsp30 formulations. The estimated mean ratios and 90% confidence intervals for the logarithm of AUC(ins,0-16h) and Cmax(ins,0-16h) were 1.022 (0.966, 1.082) and 0.949 (0.886, 1.017), respectively. Statistical analyses of AUC(ins,0-16h) and Cmax(ins,0-16h)indicated that the two formulations were bioequivalent. Further, statistical analyses of the other parameters, AUC(ins,6-16h), MRT(ins,0-inf), and t1/2 suggested that the three parameters with the New-formulation differed from those evaluated from the Existing-formulation. The differences in AUC(ins,6-16h) and MRT(ins,0-inf) between the two formulations were statistically significant (p<0.05). There were no statistically significant differences between the medians of tmax(0-16h) for both formulations. Glucose levels in serum reached a minimum at approximately 75 to 90 minutes post dose and gradually declined after 4 hours post-dose for both formulations. The glucose lowering effect of BIAsp30 was similar for the two formulations for 4 hours after dose administration, reflecting the relevant pharmacokinetic results. There were no safety concerns following subcutaneous dosing of both formulations of BIAsp30 at a dose level of 0.15 U/kg. Bioequivalence between the New-formulation and the Existing-formulation of BIAsp30 was established based on both primary endpoints, AUC(ins,0-16h) and Cmax(ins,0-16h), following subcutaneous injection of 0.15 U/kg.... (author abst.) |
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