Bioequivalence of miglitol 100mg in Korean subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000770

Enrollment

Registered

2013-06-19

Start date

2012-06-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Test drug: miglitol tablet 100mg(Kolmar) once Reference drug: miglitol tablet 100mg(diastabol) once

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Cmax;AUClast	—

Secondary

Measure	Time frame
AUCinf	—

Countries

Korea, Republic of

Contacts

Public ContactMin-Gul Kim

Chonbuk National University Hospital

mgkim@jbctc.org+82-63-250-1487

Outcome results