A Phase 1 interventional study of Januvia Tab. 100mg and Januvia Tab. 100mg + Duvie Tab. 0.5mg in Diabetes Mellitus Type 2, 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 2017-08-09.
Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate a pharmacokinetic drug interaction between sitagliptin and lobeglitazone 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:
Period 1: Treatment A(Januvia Tab. 100mg)\*1T/day for 5 days, QD, PO. Period 2: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)\*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas.
Drug: Januvia Tab. 100mg · Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg
Period 1: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)\*1T/day for 5 dyas, QD, PO. Period 2: Treatment A(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: Januvia Tab. 100mg · Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg
Januvia Tab. 100mg\*1T/day for 5days, QD, PO
Also known as: Sitagliptin 100mg
Januvia Tab.100mg + Duvie Tab. 0.5mg\*1T/day for 5 dyas, QD, PO
Also known as: Sitagliptin 100mg, Lobeglitazone 0.5mg
AUCτ of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,max of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,min of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,av of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Tss,max of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
t1/2 of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
CLss/F of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Vdss/F of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
fluctuation[(Css,max-Css,min)/Css,av] of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
swing[(Css,max-Css,min)/Css,min] of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Plan to share: No
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Chong Kun Dang Pharmaceutical