Bioequivalence of miglitol 100mg in Korean subjects
- Conditions
- Not Applicable
- Registration Number
- KCT0000770
- Lead Sponsor
- Kolmar Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax;AUClast
- Secondary Outcome Measures
Name Time Method AUCinf