Bioequivalence of miglitol 100mg in Korean subjects

Kolmar Korea0 个研究点目标入组 40 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•1. Subjects between the ages of 19 and 55 years
•2. No History of congenital or chronic disease
•3. No clinically relevant abnormalities identified by laboratory test, including Hematology, Blood chemistry, Urinalysis
•4. Female subject known to be negative for pregnant test

•1. Use of any drugs (Barbitals, alcohol) known to significantly induce or inhibit drug-metabolizing enzymes within 1 month prior to dosing
•2. Received any drugs within 10 days before the study
•3. Inappropriate subject for entry into this study in the judgement of the investigator
•4. Participating in a bioequivalence study or other clinical study within 3 month preceding the first dose of study medication
•5. Subjects who are hypersensitive to miglitol or other related compounds.
•6. Pregnancy or nursing female
•7. Patient known to be inflammatory bowel disease, ulcerative colitis, ileus
•8. Chronic bowel disease patient with malabroption condition
•9. Creatinine clearance =< 25 ml/ml

发起方

Kolmar Korea