ナテグリニド腸溶性顆粒を正常ビーグル犬に投与した時のナテグリニド溶出性，ナテグリニド血漿中濃度推移，血糖値推移の関係

抄録

The relationship among dissolution profile, plasma nateglinide concentration profiles and blood glucose levels were investigated when administering nateglinide enteric coated granules just before feeding in normal beagle dogs. As compared with nateglinide immediate release tablets, the C_max values of the enteric coated granules were lower than those of the immediate release tablets, and the T_max values of the enteric coated granules became prolonged. In the case of 5.5 of dissolution pH value, both postprandial blood glucose level (PBG) and the fasting blood glucose level (FBG) tended to be decreased. As the dissolution pH value increased, especially more than 6.5, PBG did not tend to decrease. However, FBG tended to decrease. The effect of the amount of food on nateglinide plasma concentration was evaluated using enteric coated granules with 6.5 of dissolution pH value that mainly decreased FBG. As the amount of food increased, C_max values became lower, and T_max values became prolonged. The amount of food consumed is considered to have an effect on the nateglinide plasma concentration profile of the enteric coated granules, and also the FBG lowering effect. In clinical trials using nateglinide controlled release formulation containing enteric coated granules, it is considered important to note and evaluate the amount of food, the dissolution pH value and the dissolution rate at pH 6.5.