Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4070
Source ID: NCT04349696
Associated Drug: Mitiglinide
Title: Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Liver Dysfunction
Interventions: DRUG: Mitiglinide
Outcome Measures: Primary: Peak concentration (Cmax), Pharmacokinetic of mitiglinide, 1 day|Time to reach peak concentration (Tmax), Pharmacokinetic of mitiglinide, 1day|Area under plasma concentration -time curve from time zero to time of last quantifiable concentration (AUC0-t), Pharmacokinetic of mitiglinide, 1 day|Area under the plasma concentration-time curve from time zero to infinity of mitiglinide, Pharmacokinetic of mitiglinide, 1 day|The elimination rate constant, Pharmacokinetic of mitiglinide, 1 day|Volume of distribution (Vd/F), Pharmacokinetic of mitiglinide, 1 day|Terminal elimination half-life (T1/2), Pharmacokinetic of mitiglinide, 1 day|Total body clearance (CL/F), Pharmacokinetic of mitiglinide, 1 day|Ratio of AUC0-t to AUC0-infinity, Pharmacokinetic of mitiglinide, 1 day|Area under the blood glucose concentration-time curve from time zero to time of last blood sample (AUC0-t,GLU), Pharmacokinetic of mitiglinide, 1 day|Area under the blood glucose concentration(change from baseline)-time curve from time zero to time of last blood sample (ΔAUC0-t,GLU), Pharmacokinetic of mitiglinide, 1 day|Blood glucose concentration change from baseline at 2 hours after drug administration, Pharmacokinetic of mitiglinide, 1 day |
Sponsor/Collaborators: Sponsor: Orient Europharma Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-02-11
Completion Date: 2018-04
Results First Posted:
Last Update Posted: 2021-04-30
Locations: Chiayi Chang Gung Memorial Hospital, Chiayi City, 61363, Taiwan|Taipei Veterans General Hospital, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT04349696