Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide)

PHASE4CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 11, 2014

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
Type 2 Diabetes MellitusLiver Dysfunction
Interventions
DRUG

Mitiglinide

"Day 1: one tablet of Mitiglinide 10mg with 240 ml of water approximately 5 mins before breakfast. An indwelling non-heparin catheter will be placed in an antecubital vein of the forearm or direct venipuncture will be adopted for blood sample collection at belowing time point:~For PK evaluation:~-30 (Predose), 5, 10, 15, 20, 30 min, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10 hr post dose (a total of 17 samples per subject)~For PD evaluation:~-30 (Predose), 15, 30 min, 1.0, 1.5, 2.0, 3.0, 4.0 hours post dose (a total of 8 samples per subject)"

Trial Locations (2)

11217

Taipei Veterans General Hospital, Taipei

61363

Chiayi Chang Gung Memorial Hospital, Chiayi City

All Listed Sponsors
lead

Orient Europharma Co., Ltd.

INDUSTRY

NCT04349696 - Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide) | Biotech Hunter | Biotech Hunter