Biodel Inc. (BIOD) Announces Plans To Advance BIOD-531 Based On Positive Clinical Trial Results
2/13/2014 9:09:35 AM
DANBURY, Conn., Feb. 12, 2014 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today announced preliminary results from Study 3-150, a Phase 1 clinical trial comparing Biodel's proprietary insulin formulation, BIOD-531, to the marketed products Humulin® R U-500 (U-500R) and Humalog® Mix 75/25. BIOD-531 is an ultra-rapid-acting formulation of recombinant human insulin (RHI) at a concentration of 400 units/ml (U-400) combined with EDTA, citrate and magnesium sulfate. Study 3-150 assessed the pharmacokinetic, pharmacodynamic and injection site toleration profiles of single doses of the study drugs in non-diabetic obese volunteers. The clinical trial included 1.0 U/kg and 0.5 U/kg doses of BIOD-531, as well as a 1.0 U/kg dose of Humulin® R U-500 and a 0.5 U/kg dose of Humalog® Mix 75/25.
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