A Phase 1 interventional study of Duvie Tab. 0.5mg and Duvie Tab. 0.5mg + Januvia Tab. 100mg in Diabetes Mellitus, Type II, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-11.
Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and sitagliptin in healthy male volunteers.
To healthy male subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Who had following results after examination
a. ALT or AST > twice higher than normal value
Period 1: Treatment A(Duvie Tab. 0.5mg)\*1T/day for 5 days, QD, PO Period 2: Treatment B(Duvie Tab. 0.5mg + Januvia Tab. 100mg)\*1T/day for 5 dyas, QD, PO Each treatment period was separated by a washout period of at least 10 dyas.
Drug: Duvie Tab. 0.5mg · Drug: Duvie Tab. 0.5mg + Januvia Tab. 100mg
Period 1: Treatment B(Duvie Tab. 0.5mg + Januvia Tab. 100mg)\*1T/day for 5 dyas, QD, PO Period 2: Treatment A(Duvie Tab. 0.5mg)\*1T/day for 5 days, QD, PO Each treatment period was separated by a washout period of at least 10 dyas.
Drug: Duvie Tab. 0.5mg · Drug: Duvie Tab. 0.5mg + Januvia Tab. 100mg
Duvie Tab. 0.5mg\*1T/day for 5days, QD, PO
Also known as: Lobeglitazone 0.5mg
Duvie Tab. 0.5mg + Januvia Tab.100mg\*1T/day for 5 dyas, QD, PO
Also known as: Lobeglitazone 0.5mg + Sitagliptin 100mg
AUCτ of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,max of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,min of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,av of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Tss,max of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
t1/2 of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
CLss/F of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Vdss/F of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
fluctuation[(Css,max-Css,min)/Css,av] of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
swing[(Css,max-Css,min)/Css,min] of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Plan to share: No
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Chong Kun Dang Pharmaceutical